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  1. Article ; Online: Correction: Determinants of fluid use and the association between volume of fluid used and effect of balanced solutions on mortality in critically ill patients: a secondary analysis of the BaSICS trial.

    Zampieri, Fernando G / Machado, Flavia R / Veiga, Viviane C / Azevedo, Luciano C P / Bagshaw, Sean M / Damiani, Lucas P / Cavalcanti, Alexandre B

    Intensive care medicine

    2023  Volume 50, Issue 1, Page(s) 157

    Language English
    Publishing date 2023-12-12
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 80387-x
    ISSN 1432-1238 ; 0340-0964 ; 0342-4642 ; 0935-1701
    ISSN (online) 1432-1238
    ISSN 0340-0964 ; 0342-4642 ; 0935-1701
    DOI 10.1007/s00134-023-07299-y
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    Zs.A 1089: Show issues Location:
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  2. Article ; Online: Determinants of fluid use and the association between volume of fluid used and effect of balanced solutions on mortality in critically ill patients: a secondary analysis of the BaSICS trial.

    Zampieri, Fernando G / Machado, Flavia R / Veiga, Viviane C / Azevedo, Luciano C P / Bagshaw, Sean M / Damiani, Lucas P / Cavalcanti, Alexandre B

    Intensive care medicine

    2023  Volume 50, Issue 1, Page(s) 79–89

    Abstract: Purpose: Fluid use could modulate the effect of balanced solutions (BS) on outcome of intensive care unit (ICU) patients. It is uncertain whether fluid use practices are driven more by patient features or local practices. It is also unclear whether a " ... ...

    Abstract Purpose: Fluid use could modulate the effect of balanced solutions (BS) on outcome of intensive care unit (ICU) patients. It is uncertain whether fluid use practices are driven more by patient features or local practices. It is also unclear whether a "dose-response" for the potential benefits of balanced solutions exists.
    Methods: The secondary analysis of the Balanced Solution in Intensive Care Study (BaSICS) compared 0.9% saline versus Plasma-Lyte 148
    Results: 10,505 patients were analyzed. Median fluid use in the BS arm and in the 0.9% saline arm were 2500 mL and 2488 mL, respectively. The random effect in the Bayesian regression explained 0.32 (95% credible intervals (CrI) 0.24-0.41) of all model variance (0.33, 95% credible intervals from 0.32-0.35). Frequentist and random forest models produced similar results. In the analysis including only patients alive and in the ICU at 3 days, there was a strong suggestion of interaction between fluid use and the effect of BS, driven mostly by a lower mortality with BS compared to 0.9% saline as fluid use increased for patients with sepsis. These results were consistent in the Bayesian network analysis and in an analysis based on site practices, where septic patients enrolled to BS at high fluid use sites had a lower mortality (absolute risk reduction of - 0.13 [95% credible interval - 0.27 to - 0.01]; 0.98 probability of benefit).
    Conclusion: Baseline patient characteristics collected in the BaSICS trial explain less of the variance of fluid use during the first 3 days than the enrolling site. Volume of fluid used and the effects of BS appear to interact, mostly in the sepsis subgroup where there was a strong association between fluid use after enrollment and the effect of BS on 90-day mortality.
    MeSH term(s) Humans ; Saline Solution/therapeutic use ; Critical Illness/therapy ; Bayes Theorem ; Critical Care/methods ; Fluid Therapy/methods ; Sepsis/therapy ; Intensive Care Units
    Chemical Substances Saline Solution
    Language English
    Publishing date 2023-11-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80387-x
    ISSN 1432-1238 ; 0340-0964 ; 0342-4642 ; 0935-1701
    ISSN (online) 1432-1238
    ISSN 0340-0964 ; 0342-4642 ; 0935-1701
    DOI 10.1007/s00134-023-07264-9
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  3. Article ; Online: Physiological and clinical effects of different infusion rates of intravenous fluids for volume expansion: A scoping review.

    Alves, João Antonio Milanese / Magalhães, Marcelo Rocha / Zampieri, Fernando G / Veiga, Viviane C / Maia, Israel S / Cavalcanti, Alexandre Biasi

    Journal of critical care

    2023  Volume 76, Page(s) 154295

    Abstract: Purpose: To assess the physiological and clinical effects of different rates of intravenous fluids for volume expansion of critically ill and perioperative patients.: Methods: We searched PubMed, EMBASE, and Cochrane Central Register of Controlled ... ...

    Abstract Purpose: To assess the physiological and clinical effects of different rates of intravenous fluids for volume expansion of critically ill and perioperative patients.
    Methods: We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for studies comparing intravenous infusion rates both in animals and studies involving healthy subjects, critically ill, and perioperative care patients of all ages.
    Results: Seven animal studies, eleven clinical studies and three studies including healthy volunteers were identified. Slower infusion led to lower mortality in two studies, lower blood loss in one study, better or more sustained expansion of plasma volume and less edema in three studies, but slower restoration of blood pressure in one study. Three healthy volunteer studies suggested more effective plasma expansion with slower infusion, whereas one trial with postoperative patients did not show plasma volume differences between different infusion rates. One randomized trial found increased mortality with faster infusion in septic children, whereas a randomized trial found no significant differences in critically ill adults.
    Conclusions: In this scoping review, most studies showed that slower intravenous infusion rates result in a more efficient intravascular expansion, with a longer effect, and less edema than faster rates. Effects on clinical outcomes were inconsistent.
    MeSH term(s) Humans ; Critical Illness ; Infusions, Intravenous
    Language English
    Publishing date 2023-03-29
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 632818-0
    ISSN 1557-8615 ; 0883-9441
    ISSN (online) 1557-8615
    ISSN 0883-9441
    DOI 10.1016/j.jcrc.2023.154295
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  4. Article ; Online: Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials.

    Siempos, Ilias I / Kalil, Andre C / Belhadi, Drifa / Veiga, Viviane Cordeiro / Cavalcanti, Alexandre Biasi / Branch-Elliman, Westyn / Papoutsi, Eleni / Gkirgkiris, Konstantinos / Xixi, Nikoleta A / Kotanidou, Anastasia / Hermine, Olivier / Porcher, Raphaël / Mariette, Xavier

    EClinicalMedicine

    2024  Volume 69, Page(s) 102472

    Abstract: Background: Although immunomodulators have established benefit against the new coronavirus disease (COVID-19) in general, it is uncertain whether such agents improve outcomes without increasing the risk of secondary infections in the specific subgroup ... ...

    Abstract Background: Although immunomodulators have established benefit against the new coronavirus disease (COVID-19) in general, it is uncertain whether such agents improve outcomes without increasing the risk of secondary infections in the specific subgroup of previously immunocompromised patients. We assessed the effect of immunomodulators on outcomes of immunocompromised patients hospitalized for COVID-19.
    Methods: The protocol was prospectively registered with PROSPERO (CRD42022335397). MEDLINE, Cochrane Central Register of Controlled Trials and references of relevant articles were searched up to 01-06-2022. Authors of potentially eligible randomized controlled trials were contacted to provide data on immunocompromised patients randomized to immunomodulators vs control (i.e., placebo or standard-of-care).
    Findings: Eleven randomized controlled trials involving 397 immunocompromised patients hospitalized for COVID-19 were included. Ten trials had low risk of bias. There was no difference between immunocompromised patients randomized to immunomodulators vs control regarding mortality [30/182 (16.5%) vs 41/215 (19.1%); RR 0.93, 95% CI 0.61-1.41; p = 0.74], secondary infections (RR 1.00, 95% CI 0.64-1.58; p = 0.99) and change in World Health Organization ordinal scale from baseline to day 15 (weighed mean difference 0.27, 95% CI -0.09-0.63; p = 0.15). In subgroup analyses including only patients with hematologic malignancy, only trials with low risk of bias, only trials administering IL-6 inhibitors, or only trials administering immunosuppressants, there was no difference between comparators regarding mortality.
    Interpretation: Immunomodulators, compared to control, were not associated with harmful or beneficial outcomes, including mortality, secondary infections, and change in ordinal scale, when administered to immunocompromised patients hospitalized for COVID-19.
    Funding: Hellenic Foundation for Research and Innovation.
    Language English
    Publishing date 2024-02-09
    Publishing country England
    Document type Journal Article
    ISSN 2589-5370
    ISSN (online) 2589-5370
    DOI 10.1016/j.eclinm.2024.102472
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  5. Article ; Online: Conditional Treatment Effect Analysis of Two Infusion Rates for Fluid Challenges in Critically Ill Patients: A Secondary Analysis of Balanced Solution versus Saline in Intensive Care Study (BaSICS) Trial.

    Zampieri, Fernando G / Damiani, Lucas P / Bagshaw, Sean M / Semler, Matthew W / Churpek, Matthew / Azevedo, Luciano C P / Figueiredo, Rodrigo C / Veiga, Viviane C / Biondi, Rodrigo / Freitas, Flavio R / Machado, Flavia R / Cavalcanti, Alexandre B

    Annals of the American Thoracic Society

    2023  Volume 20, Issue 6, Page(s) 872–879

    Abstract: Rationale: ...

    Abstract Rationale:
    MeSH term(s) Humans ; Bayes Theorem ; Critical Care ; Critical Illness/therapy ; Fluid Therapy/adverse effects ; Fluid Therapy/methods ; Research Design
    Language English
    Publishing date 2023-02-03
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2717461-X
    ISSN 2325-6621 ; 1943-5665 ; 2325-6621
    ISSN (online) 2325-6621 ; 1943-5665
    ISSN 2325-6621
    DOI 10.1513/AnnalsATS.202211-946OC
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    Zs.A 5828: Show issues Location:
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  6. Article ; Online: Efficacy and safety of tocilizumab in COVID-19 patients: a living systematic review and meta-analysis, first update.

    Tleyjeh, Imad M / Kashour, Zakariya / Riaz, Muhammad / Hassett, Leslie / Veiga, Viviane C / Kashour, Tarek

    Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

    2021  Volume 27, Issue 8, Page(s) 1076–1082

    Abstract: Objectives: Cytokine release syndrome with elevated interleukin-6 (IL-6) levels is associated with multiorgan damage and death in severe coronavirus disease 2019 (COVID-19). Our objective was to update the data in a living systematic review of the ... ...

    Abstract Objectives: Cytokine release syndrome with elevated interleukin-6 (IL-6) levels is associated with multiorgan damage and death in severe coronavirus disease 2019 (COVID-19). Our objective was to update the data in a living systematic review of the literature concerning the efficacy and toxicity of the IL-6 receptor antagonist tocilizumab in COVID-19 patients.
    Methods: Data sources were Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Web of Science, Scopus up, preprint servers and Google from 8th October 2020 till 24th February 2021. Eligible studies were randomized controlled trials (RCTs) and observational studies at low or moderate risk of bias. The participants were hospitalized COVID-19 patients, and intervention was tocilizumab versus placebo or standard of care. We pooled crude risk ratios (RRs) of RCTs with a random effects model and evaluated inconsistency between studies with I
    Results: Of 1600 citations, eight RCTs and 28 cohorts were eligible. The eight RCTs had low risk of bias, and with 6311 patients they examined the effect of tocilizumab on short-term mortality; pooled RR was 0.91 (95%CI 0.78-1.07, I
    Conclusions: Cumulative high-certainty evidence shows that tocilizumab reduces the risk of mechanical ventilation in hospitalized patients with severe COVID-19. Moderate-certainty evidence shows that tocilizumab reduces the risk of poor outcome and the risk of secondary infections in hospitalized COVID-19 patients. This review will continuously evaluate the role of tocilizumab in COVID-19 treatment.
    MeSH term(s) Antibodies, Monoclonal, Humanized/therapeutic use ; COVID-19/drug therapy ; COVID-19/epidemiology ; COVID-19/virology ; Humans ; Immunosuppressive Agents/therapeutic use ; Interleukin-6/antagonists & inhibitors ; Interleukin-6/blood ; Odds Ratio ; Placebos ; Respiration, Artificial ; SARS-CoV-2/drug effects ; Standard of Care ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal, Humanized ; Immunosuppressive Agents ; Interleukin-6 ; Placebos ; tocilizumab (I031V2H011)
    Language English
    Publishing date 2021-04-27
    Publishing country England
    Document type Journal Article ; Meta-Analysis ; Systematic Review
    ZDB-ID 1328418-6
    ISSN 1469-0691 ; 1470-9465 ; 1198-743X
    ISSN (online) 1469-0691
    ISSN 1470-9465 ; 1198-743X
    DOI 10.1016/j.cmi.2021.04.019
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    Zs.A 4541: Show issues Location:
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  7. Article ; Online: Rivaroxaban in Outpatients with Mild or Moderate COVID-19: Rationale and Design of the Study CARE (CARE - Coalition COVID-19 Brazil VIII).

    Oliveira, Gustavo B F / Neves, Precil Diego M M / Oliveira, Haliton A / Catarino, Daniela Ghidetti Mangas / Alves, Lucas B O / Cavalcanti, Alexandre B / Rosa, Regis G / Veiga, Viviane C / Azevedo, Luciano C P / Berwanger, Otávio / Lopes, Renato D / Avezum, Álvaro

    Arquivos brasileiros de cardiologia

    2023  Volume 120, Issue 3, Page(s) e20220431

    Abstract: Background: Previous studies have demonstrated a high risk of arterial and venous thromboembolic events as a consequence of direct viral damage to endothelial cells by SARS-CoV-2 and a procoagulant milieu due to increased biomarkers, such as D-dimer, ... ...

    Title translation Rivaroxabana em Pacientes Ambulatoriais com COVID-19 Leve ou Moderada: Fundamentação e Desenho do Estudo CARE (CARE – Coalition COVID-19 Brazil VIII).
    Abstract Background: Previous studies have demonstrated a high risk of arterial and venous thromboembolic events as a consequence of direct viral damage to endothelial cells by SARS-CoV-2 and a procoagulant milieu due to increased biomarkers, such as D-dimer, fibrinogen, and factor VIII. Although randomized controlled trials of antithrombotic therapies have been conducted in hospitalized patients, few have evaluated the role of thromboprophylaxis in an outpatient setting.
    Objective: To assess whether antithrombotic prophylaxis with rivaroxaban reduces the risk of venous or arterial thrombotic events, invasive ventilatory support, and death in COVID-19 outpatients.
    Methods: The COVID Antithrombotic Rivaroxaban Evaluation (CARE) study, a multicenter, randomized, open-label, controlled trial of rivaroxaban 10 mg once daily for 14 days or local standard treatment alone to prevent adverse outcomes, is registered in clinicaltrials.gov (NCT04757857). The inclusion criteria are adults with confirmed or suspected SARS-CoV-2 infection and mild or moderate symptoms without indication for hospitalization, within 7 days of symptom onset, and 1 risk factor for COVID-19 complication (> 65 years, hypertension, diabetes mellitus, asthma, chronic obstructive pulmonary disease or other chronic lung diseases, smoking, immunosuppression, or obesity). The primary composite endpoint, which includes venous thromboembolism, invasive mechanical ventilation, major acute cardiovascular events, and mortality within 30 days of randomization, will be assessed according to the intention-to-treat principle. All patients will provide informed consent. A significance level of 5% will be used for all statistical tests.
    Results: Major thrombotic and bleeding outcomes, hospitalizations, and deaths will be centrally adjudicated by an independent clinical events committee blinded to the assigned treatment groups.
    Conclusion: The CARE study will provide relevant and contemporary information about the potential role of thromboprophylaxis in outpatients with COVID-19.
    MeSH term(s) Adult ; Humans ; COVID-19 ; SARS-CoV-2 ; Rivaroxaban ; Outpatients ; Anticoagulants ; Brazil ; Endothelial Cells ; Fibrinolytic Agents ; Venous Thromboembolism ; Thrombosis ; Treatment Outcome ; Randomized Controlled Trials as Topic
    Chemical Substances Rivaroxaban (9NDF7JZ4M3) ; Anticoagulants ; Fibrinolytic Agents
    Language Portuguese
    Publishing date 2023-04-05
    Publishing country Brazil
    Document type Multicenter Study ; Journal Article
    ZDB-ID 730261-7
    ISSN 1678-4170 ; 0066-782X
    ISSN (online) 1678-4170
    ISSN 0066-782X
    DOI 10.36660/abc.20220431
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  8. Article: A Randomized, Open-Label, Non-inferiority Clinical Trial Assessing 7 Versus 14 Days of Antimicrobial Therapy for Severe Multidrug-Resistant Gram-Negative Bacterial Infections: The OPTIMISE Trial Protocol.

    Arns, Beatriz / Horvath, Jaqueline Driemeyer C / Rech, Gabriela Soares / Sesin, Guilhermo Prates / Agani, Crepin Aziz Jose Oluwafoumi / da Rosa, Bruna Silveira / Dos Santos, Tiago Marcon / Brochier, Liliane Spencer Bittencourt / Cavalcanti, Alexandre Biasi / Tomazini, Bruno Martins / Pereira, Adriano Jose / Veiga, Viviane Cordeiro / Nascimento, Giovana Marssola / Kalil, Andre C / Zavascki, Alexandre P

    Infectious diseases and therapy

    2023  Volume 13, Issue 1, Page(s) 237–250

    Abstract: Introduction: Shorter courses of antimicrobials have been shown to be non-inferior to longer, "traditional" duration of therapies, including for some severe healthcare-associated infections, with a few exceptions. However, evidence is lacking regarding ... ...

    Abstract Introduction: Shorter courses of antimicrobials have been shown to be non-inferior to longer, "traditional" duration of therapies, including for some severe healthcare-associated infections, with a few exceptions. However, evidence is lacking regarding shorter regimes against severe infections by multidrug-resistant Gram-negative bacteria (MDR-GNB), which are often caused by distinct strains and commonly treated with second-line antimicrobials. In the duratiOn of theraPy in severe infecTIons by MultIdrug-reSistant gram-nEgative bacteria (OPTIMISE) trial, we aim to assess the non-inferiority of 7-day versus 14-day antimicrobial therapy in critically ill patients with severe infections caused by MDR-GNB.
    Methods: This is a randomized, multicenter, open-label, parallel controlled trial to assess the non-inferiority of 7-day versus 14-day of adequate antimicrobial therapy for intensive care unit (ICU)-acquired severe infections by MDR-GNB. Adult patients with severe infections by MDR-GNB initiated after 48 h of ICU admission are screened for eligibility. Patients are eligible if they proved to be hemodynamically stable and without fever for at least 48 h on the 7th day of adequate antimicrobial therapy. After consenting, patients are 1:1 randomized to discontinue antimicrobial therapy on the 7th (± 1) day or to continue for a total of 14th (± 1) days.
    Planned outcomes: The primary outcome is treatment failure, defined as death or relapse of infection within 28 days after randomization. Non-inferiority will be achieved if the upper edge of the two-tailed 95% confidence interval of the difference between the clinical failure rate in the 7-day and the 14-day group is not higher than 10%.
    Conclusion: The OPTIMISE trial is the first randomized controlled trial specifically designed to assess the duration of antimicrobial therapy in patients with severe infections by MDR-GNB.
    Trial registration: ClinicalTrials.gov, NCT05210387. Registered on 27 January 2022. Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections (OPTIMISE).
    Language English
    Publishing date 2023-12-16
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2701611-0
    ISSN 2193-6382 ; 2193-8229
    ISSN (online) 2193-6382
    ISSN 2193-8229
    DOI 10.1007/s40121-023-00897-9
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  9. Article ; Online: Rationale and Design of the COVID-19 Outpatient Prevention Evaluation (COPE - Coalition V) Randomized Clinical Trial: Hydroxychloroquine vs. Placebo in Non-Hospitalized Patients.

    Oliveira Junior, Haliton Alves de / Ferri, Cleusa P / Boszczowski, Icaro / Oliveira, Gustavo B F / Cavalcanti, Alexandre B / Rosa, Regis G / Lopes, Renato D / Azevedo, Luciano C P / Veiga, Viviane C / Berwanger, Otavio / Avezum, Álvaro

    Arquivos brasileiros de cardiologia

    2022  Volume 118, Issue 2, Page(s) 378–387

    Abstract: Background: Despite the need for targeting specific therapeutic options for coronavirus disease 2019 (COVID-19), there has been no evidence of effectiveness of any specific treatment for the outpatient clinical setting. There are few randomized studies ... ...

    Title translation Justificativa e Desenho do Ensaio Clínico Randomizado COVID-19 Outpatient Prevention Evaluation (COPE - Coalition V): Hidroxicloroquina vs. Placebo em Pacientes Não Hospitalizados.
    Abstract Background: Despite the need for targeting specific therapeutic options for coronavirus disease 2019 (COVID-19), there has been no evidence of effectiveness of any specific treatment for the outpatient clinical setting. There are few randomized studies evaluating hydroxychloroquine (HCQ) in non-hospitalized patients. These studies indicate no benefit from the use of HCQ, but they assessed different primary outcomes and presented important biases for outcome evaluation.
    Objective: To evaluate if HCQ may prevent hospitalization due to COVID-19 compared to a matching placebo.
    Methods: The COVID-19 Outpatient Prevention Evaluation (COPE) study is a pragmatic, randomized, double-blind, placebo-controlled clinical trial evaluating the use of HCQ (800 mg on day 1 and 400 mg from day 2 to day 7) or matching placebo for the prevention of hospitalization due to COVID-19 in early non-hospitalized confirmed or suspected cases. Inclusion criteria are adults (≥ 18 years) seeking medical care with mild symptoms of COVID-19, with randomization ≤ 7 days after symptom onset, without indication of hospitalization at study screening, and with at least one risk factor for complication (> 65 years; hypertension; diabetes mellitus; asthma; chronic obstructive pulmonary disease or other chronic lung diseases; smoking; immunosuppression; or obesity). All hypothesis tests will be two-sided. A p-value < 0.05 will be considered statistically significant in all analyses. Clinicaltrials.gov: NCT04466540.
    Results: Clinical outcomes will be centrally adjudicated by an independent clinical event committee blinded to the assigned treatment groups. The primary efficacy endpoint will be assessed following the intention-to-treat principle.
    Conclusion: This study has the potential to reliably answer the scientific question of HCQ use in outpatients with COVID-19. To our knowledge, this is the largest trial evaluating HCQ in non-hospitalized individuals with COVID-19.
    MeSH term(s) Adult ; COVID-19/drug therapy ; Humans ; Hydroxychloroquine/adverse effects ; Hydroxychloroquine/therapeutic use ; Outpatients ; SARS-CoV-2 ; Treatment Outcome
    Chemical Substances Hydroxychloroquine (4QWG6N8QKH)
    Language Portuguese
    Publishing date 2022-03-07
    Publishing country Brazil
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 730261-7
    ISSN 1678-4170 ; 0066-782X
    ISSN (online) 1678-4170
    ISSN 0066-782X
    DOI 10.36660/abc.20210832
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  10. Article ; Online: Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS).

    Zampieri, Fernando G / Damiani, Lucas P / Biondi, Rodrigo S / Freitas, Flávio G R / Veiga, Viviane C / Figueiredo, Rodrigo C / Serpa-Neto, Ary / Manoel, Airton L O / Miranda, Tamiris A / Corrêa, Thiago D / Azevedo, Luciano C P / Silva, Nilton B / Machado, Flavia R / Cavalcanti, Alexandre B

    Journal of critical care

    2022  Volume 71, Page(s) 154113

    Abstract: Purpose: To reanalyze the results of the Balanced Solutions in Intensive Care Study (BaSICS) through hierarchical endpoint analysis with win ratio.: Methods: All patients with full data in BaSICS trial were elected for the analysis. BaSICS compared ... ...

    Abstract Purpose: To reanalyze the results of the Balanced Solutions in Intensive Care Study (BaSICS) through hierarchical endpoint analysis with win ratio.
    Methods: All patients with full data in BaSICS trial were elected for the analysis. BaSICS compared balanced solutions (Plasma Lye 148) versus 0.9% saline in critically ill patients requiring fluid challenge. The win ratio was defined as a hierarchical endpoint of 90-day mortality, recepit of kidney replacement therapy, hospital length-of-stay (LOS), and intensive care unit (ICU) LOS. Both unstratified and stratified (by admission type: planned admission, unplanned admission with sepsis, and unplanned admission without sepsis) approaches were used. A subgroup analysis was performed in patients with traumatic brain injury.
    Results: A total of 10,490 patients were included in the analysis, resulting in 27,587,566 unique combinations for unstratified WR. Unstratified Win ratio was 1.02 (95% confidence interval 0.97; 1.07), which was similar to stratified WR. No stratum in the stratified analysis resulted in significant results. Subgroup analysis confirmed the possible harm of balanced solutions in traumatic brain injury patients (WR 0.80; 95% confidence interval 0.64; 0.99).
    Conclusion: In this reanalysis of BaSICS, a win ratio analysis largely replicated the results of the main trial, yielding neutral results except for the subgroup of patients with traumatic brain injury where a signal of harm was found.
    MeSH term(s) Brain Injuries, Traumatic/therapy ; Critical Care ; Critical Illness/therapy ; Hospital Mortality ; Humans ; Intensive Care Units ; Sepsis
    Language English
    Publishing date 2022-07-14
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632818-0
    ISSN 1557-8615 ; 0883-9441
    ISSN (online) 1557-8615
    ISSN 0883-9441
    DOI 10.1016/j.jcrc.2022.154113
    Database MEDical Literature Analysis and Retrieval System OnLINE

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