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  1. Article ; Online: Clinical outcome of COVID-19 in patients with adult congenital heart disease.

    Schwerzmann, Markus / Ruperti-Repilado, Francisco Javier / Baumgartner, Helmut / Bouma, Berto / Bouchardy, Judith / Budts, Werner / Campens, Laurence / Chessa, Massimo / Del Cerro Marin, Maria Jesús / Gabriel, Harald / Gallego, Pastora / Garcia-Orta, Rocio / Gonzalez, Ana Elvira / Jensen, Annette Schophuus / Ladouceur, Magalie / Miranda-Barrio, Berta / Morissens, Marielle / Pasquet, Agnes / Rueda, Joaquín /
    van den Bosch, Annemien E / van der Zwaan, Heleen Berdina / Tobler, Daniel / Greutmann, Matthias

    Heart (British Cardiac Society)

    2021  Volume 107, Issue 15, Page(s) 1226–1232

    Abstract: Aims: Patients with adult congenital heart disease (ACHD) are a potentially vulnerable patient ... outcome data and to identify risk factors for a complicated course of COVID-19 in patients with ACHD ... patients with ACHD diagnosed with COVID-19 presenting to one of the participating centres between 27 March ...

    Abstract Aims: Patients with adult congenital heart disease (ACHD) are a potentially vulnerable patient cohort in case of COVID-19. Some cardiac defects may be associated with a poor COVID-19 outcome. Risk estimation in ACHD is currently based on expert opinion. The aim of this study was to collect clinical outcome data and to identify risk factors for a complicated course of COVID-19 in patients with ACHD.
    Methods: Twenty-five ACHD centres in nine European countries participated in the study. Consecutive patients with ACHD diagnosed with COVID-19 presenting to one of the participating centres between 27 March and 6 June 2020 were included. A complicated disease course was defined as hospitalisation for COVID-19 requiring non-invasive or invasive ventilation and/or inotropic support, or a fatal outcome.
    Results: Of 105 patients with a mean age of 38±13 years (58% women), 13 had a complicated disease course, of whom 5 died. In univariable analysis, age (OR 1.3, 95% CI 1.1 to 1.7, per 5 years), ≥2 comorbidities (OR 7.1, 95% CI 2.1 to 24.5), body mass index of >25 kg/m
    Conclusions: Among patients with ACHD, general risk factors (age, obesity and multiple comorbidities) are associated with an increased risk of complicated COVID-19 course. Congenital cardiac defects at particularly high risk were cyanotic lesions, including unrepaired cyanotic defects or Eisenmenger syndrome.
    Language English
    Publishing date 2021-07-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 1303417-0
    ISSN 1468-201X ; 1355-6037
    ISSN (online) 1468-201X
    ISSN 1355-6037
    DOI 10.1136/heartjnl-2020-318467
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Clinical Outcomes of SARS-CoV-2 Infection in Pediatric Patients on Ventricular Assist Device Support: An ACTION Registry Analysis.

    Torpoco Rivera, Diana M / Joong, Anna / D'Souza, Nikita / Duganiero, Toni / Lorts, Angela / Spinner, Joseph A

    ASAIO journal (American Society for Artificial Internal Organs : 1992)

    2023  Volume 70, Issue 2, Page(s) 154–158

    Abstract: Adult patients on left ventricular assist device (LVAD) support have increased morbidity and ... reported clinical data describing outcomes among pediatric patients on ventricular assist device (VAD ... from 16 centers tested positive for SARS-CoV-2. Cardiomyopathy (59.1%) and congenital heart disease (40.9 ...

    Abstract Adult patients on left ventricular assist device (LVAD) support have increased morbidity and mortality after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. There are no reported clinical data describing outcomes among pediatric patients on ventricular assist device (VAD) support infected with SARS-CoV-2. We conducted a retrospective study using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry to evaluate patient characteristics and clinical outcomes after SARS-CoV-2 infection. A total of 22 children on VAD support (median age at infection 10.6 years) from 16 centers tested positive for SARS-CoV-2. Cardiomyopathy (59.1%) and congenital heart disease (40.9%) were the most common primary diagnoses. The type of support included LVAD in 19 (86.4%), biventricular assist device (BIVAD) in one (4.5%), and single ventricle VAD in two (9%) patients. At the time of infection, 50% were outpatients, 23% were inpatients on a general cardiology floor, and 27% were in the cardiac intensive care unit (CICU). Most patients (82%) were symptomatic at time of diagnosis, but only 13% required escalation of respiratory support, and 31% received SARS-CoV-2 therapies. Notably, no mortality occurred, and significant morbidity was rare after SARS-CoV-2 infection in pediatric patients on VAD support.
    MeSH term(s) Adult ; Humans ; Child ; Heart-Assist Devices/adverse effects ; Heart Failure/therapy ; Retrospective Studies ; Treatment Outcome ; COVID-19 ; SARS-CoV-2 ; Registries
    Language English
    Publishing date 2023-10-20
    Publishing country United States
    Document type Journal Article
    ZDB-ID 759982-1
    ISSN 1538-943X ; 0162-1432 ; 1058-2916
    ISSN (online) 1538-943X
    ISSN 0162-1432 ; 1058-2916
    DOI 10.1097/MAT.0000000000002080
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation

    Ali Dabbagh / Samira Rajaei / Mehdi Ghahremani / Mohammad Fathi / Nilofar Massoudi / Sasan Tavana / Kamal Fani / Navid Nooraee / Nasser Malekpour Alamdari / Sara Besharat / Arash Najafi Abrandabadi / Ali Pirsalehi / Mohammad Ali Khabiri Khatiri

    Trials, Vol 21, Iss 1, Pp 1-

    A structured summary of a study protocol for a randomised controlled trial

    2020  Volume 3

    Abstract: ... pulmonary disease in addition to COVID-19 ● Underlying congenital heart diseasePatients needing ... criteria: Adult COVID-19 patients admitted to the ICU in Modarres hospital, Tehran, Iran (age range of 18 ... Abstract Objectives Assessing the effect of surfactant on clinical outcome in patients with COVID ...

    Abstract Abstract Objectives Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under mechanical ventilation Trial design Single centre, two arm, parallel group (1:1 allocation ratio), randomised superiority trial with blinded care and outcome assessment. Participants Inclusion criteria: Adult COVID-19 patients admitted to the ICU in Modarres hospital, Tehran, Iran (age range of 18 to 99 years) with moderate to severe ARDS (based on definition of P/F ratio) requiring auxiliary respiratory devices (either intubation or face mask). Exclusion criteria: ● Existence of a major underlying pulmonary disease in addition to COVID-19 ● Underlying congenital heart diseasePatients needing extracorporeal membrane oxygenation (ECMO) ● ARDS primarily due to any other reason rather than COVID-19 ● The primary source of pulmonary involvement was bacterial pneumonia or any other etiology except for COVID-10 induced lung involvement ● Those who refused to continue the study (either the patient or their family) ● any patient had any sign of healing before entering the study leading to discharge from ICU in less than 12 hours Intervention and comparator In the intervention group, the dose of the drug is a vial containing 4 ml, equivalent to 100 mg, which is prescribed for an adult weighing about 70 kg each time, and if the patient's weight is much lower or higher, it will be adjusted accordingly. Surfactant is prescribed inside the trachea in two doses, starting on the day of intubation with a second dose 6 hours later. The control group will receive the same volume of normal saline, based on weight, administered into the trachea with the same time schedule. Main outcomes 30 days mortality; patient mortality during stay in ICU up to 30 days; ICU length of stay up to 30 days; Time under mechanical ventilation up to 30 days. Randomisation After the participant enters the study, i.e. after the qualification of the patients in the trial is confirmed and their informed written consent is taken, we will use a ...
    Keywords COVID-19 ; SARS-COV-2 ; surfactant ; ICU ; acute respiratory distress syndrome ; ventilator ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2020-11-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial.

    Dabbagh, Ali / Rajaei, Samira / Ghahremani, Mehdi / Fathi, Mohammad / Massoudi, Nilofar / Tavana, Sasan / Fani, Kamal / Nooraee, Navid / Malekpour Alamdari, Nasser / Besharat, Sara / Najafi Abrandabadi, Arash / Pirsalehi, Ali / Khabiri Khatiri, Mohammad Ali

    Trials

    2020  Volume 21, Issue 1, Page(s) 919

    Abstract: ... in addition to COVID-19 ● Underlying congenital heart diseasePatients needing ... Objectives: Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under ... superiority trial with blinded care and outcome assessment.: Participants: Inclusion criteria: Adult COVID ...

    Abstract Objectives: Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under mechanical ventilation TRIAL DESIGN: Single centre, two arm, parallel group (1:1 allocation ratio), randomised superiority trial with blinded care and outcome assessment.
    Participants: Inclusion criteria: Adult COVID-19 patients admitted to the ICU in Modarres hospital, Tehran, Iran (age range of 18 to 99 years) with moderate to severe ARDS (based on definition of P/F ratio) requiring auxiliary respiratory devices (either intubation or face mask).
    Exclusion criteria: ● Existence of a major underlying pulmonary disease in addition to COVID-19 ● Underlying congenital heart diseasePatients needing extracorporeal membrane oxygenation (ECMO) ● ARDS primarily due to any other reason rather than COVID-19 ● The primary source of pulmonary involvement was bacterial pneumonia or any other etiology except for COVID-10 induced lung involvement ● Those who refused to continue the study (either the patient or their family) ● any patient had any sign of healing before entering the study leading to discharge from ICU in less than 12 hours INTERVENTION AND COMPARATOR: In the intervention group, the dose of the drug is a vial containing 4 ml, equivalent to 100 mg, which is prescribed for an adult weighing about 70 kg each time, and if the patient's weight is much lower or higher, it will be adjusted accordingly. Surfactant is prescribed inside the trachea in two doses, starting on the day of intubation with a second dose 6 hours later. The control group will receive the same volume of normal saline, based on weight, administered into the trachea with the same time schedule.
    Main outcomes: 30 days mortality; patient mortality during stay in ICU up to 30 days; ICU length of stay up to 30 days; Time under mechanical ventilation up to 30 days.
    Randomisation: After the participant enters the study, i.e. after the qualification of the patients in the trial is confirmed and their informed written consent is taken, we will use a simple randomisation method using a table of random numbers. In order to hide the random allocation process, a central randomisation approach will be used and the random sequence will be at the disposal of one of the researchers, excluding the principal investigator.
    Blinding (masking): Participants, healthcare providers and the principal investigator assessing the outcomes will all be blinded to the group assignment.
    Numbers to be randomised (sample size): A total of 60 participants will be randomised in a 1:1 allocation ratio (30 patients allocated to the intervention group and 30 patients allocated to the control group).
    Trial status: The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020.
    Trial registration: IRCT registration number: IRCT20091201002804N12 Registration date: 1st June 2020, 1399/03/12 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
    MeSH term(s) Adult ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/therapy ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Dosage Calculations ; Drug Monitoring/methods ; Female ; Humans ; Male ; Mortality ; Pandemics ; Pneumonia, Viral/therapy ; Pulmonary Surfactants/administration & dosage ; Pulmonary Surfactants/adverse effects ; Randomized Controlled Trials as Topic ; Respiration, Artificial/methods ; SARS-CoV-2 ; Surface-Active Agents/administration & dosage ; Surface-Active Agents/adverse effects ; Treatment Outcome
    Chemical Substances Pulmonary Surfactants ; Surface-Active Agents
    Keywords covid19
    Language English
    Publishing date 2020-11-11
    Publishing country England
    Document type Clinical Trial Protocol ; Letter
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-020-04815-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial

    Dabbagh, Ali / Rajaei, Samira / Ghahremani, Mehdi / Fathi, Mohammad / Massoudi, Nilofar / Tavana, Sasan / Fani, Kamal / Nooraee, Navid / Malekpour Alamdari, Nasser / Besharat, Sara / Najafi Abrandabadi, Arash / Pirsalehi, Ali / Khabiri Khatiri, Mohammad Ali

    Trials

    Abstract: ... to COVID-19 ● Underlying congenital heart disease ● Patients needing ... OBJECTIVES: Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under ... superiority trial with blinded care and outcome assessment. PARTICIPANTS: Inclusion criteria: Adult COVID-19 ...

    Abstract OBJECTIVES: Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under mechanical ventilation TRIAL DESIGN: Single centre, two arm, parallel group (1:1 allocation ratio), randomised superiority trial with blinded care and outcome assessment. PARTICIPANTS: Inclusion criteria: Adult COVID-19 patients admitted to the ICU in Modarres hospital, Tehran, Iran (age range of 18 to 99 years) with moderate to severe ARDS (based on definition of P/F ratio) requiring auxiliary respiratory devices (either intubation or face mask). EXCLUSION CRITERIA: ● Existence of a major underlying pulmonary disease in addition to COVID-19 ● Underlying congenital heart disease ● Patients needing extracorporeal membrane oxygenation (ECMO) ● ARDS primarily due to any other reason rather than COVID-19 ● The primary source of pulmonary involvement was bacterial pneumonia or any other etiology except for COVID-10 induced lung involvement ● Those who refused to continue the study (either the patient or their family) ● any patient had any sign of healing before entering the study leading to discharge from ICU in less than 12 hours INTERVENTION AND COMPARATOR: In the intervention group, the dose of the drug is a vial containing 4 ml, equivalent to 100 mg, which is prescribed for an adult weighing about 70 kg each time, and if the patient's weight is much lower or higher, it will be adjusted accordingly. Surfactant is prescribed inside the trachea in two doses, starting on the day of intubation with a second dose 6 hours later. The control group will receive the same volume of normal saline, based on weight, administered into the trachea with the same time schedule. MAIN OUTCOMES: 30 days mortality; patient mortality during stay in ICU up to 30 days; ICU length of stay up to 30 days; Time under mechanical ventilation up to 30 days. RANDOMISATION: After the participant enters the study, i.e. after the qualification of the patients in the trial is confirmed and their informed written consent is taken, we will use a simple randomisation method using a table of random numbers. In order to hide the random allocation process, a central randomisation approach will be used and the random sequence will be at the disposal of one of the researchers, excluding the principal investigator. BLINDING (MASKING): Participants, healthcare providers and the principal investigator assessing the outcomes will all be blinded to the group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 60 participants will be randomised in a 1:1 allocation ratio (30 patients allocated to the intervention group and 30 patients allocated to the control group). TRIAL STATUS: The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020. TRIAL REGISTRATION: IRCT registration number: IRCT20091201002804N12 Registration date: 1st June 2020, 1399/03/12 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #917940
    Database COVID19

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