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  1. Article ; Online: Treatment with IgM-enriched immunoglobulin in sepsis: a matched case-control analysis.

    Martinez, Jorge-Ignacio / Sánchez, Hector-Fabio / Velandia, Julio-Alberto / Urbina, Zulma / Florián, María-Cristina / Martínez, Mauricio-Antonio / Giamarellos-Bourboulis, Evangelos J / Pino-Pinzón, Carmen-Juliana / Ortiz, Guillermo / Celis, Edgar

    Journal of critical care

    2021  Volume 64, Page(s) 120–124

    Abstract: The therapeutic potential of IgM-enriched immunoglobulin preparations (IgGAM) in sepsis remains a field of debate. The use of polyclonal immunoglobulins as adjuvant therapy (Esen & Tugrul, 2009; Kaukonen et al., 2014; Molnár et al., 2013; Taccone et al., ...

    Abstract The therapeutic potential of IgM-enriched immunoglobulin preparations (IgGAM) in sepsis remains a field of debate. The use of polyclonal immunoglobulins as adjuvant therapy (Esen & Tugrul, 2009; Kaukonen et al., 2014; Molnár et al., 2013; Taccone et al., 2009) has been shown to improve clinical outcomes in terms of mortality. This study analyze the impact of IgM-enriched IgG (IgGM) as additional immunomodulation. Patients and methods: This is a retrospective registry of 1196 patients with severe sepsis and septic shock from nine Intensive Care Units in Colombia, from routine clinical practice; 220 patients treated with IgGAM were registered. Fully matched comparators for severity and type of infection selected among patients non-treated with IgGAM. Mortality after 28 days was 30.5% among IgGAM-treated patients and 40.5% among matched comparators. Results: Multivariate Cox regression analysis showed IgGAM treatment to be the only variable protective from death after 28 days (hazard ratio 0.62; 0.45-0.86; p: 0.004). Results reinforce the importance of IgGAM treatment for favorable outcome after septic shock and are in line with recent published meta-analyses. This study showed that treatment with IgGM in patients with sepsis was an independent modulator of the 28-day associated with a lower mortality.
    MeSH term(s) Humans ; Immunoglobulin M ; Intensive Care Units ; Retrospective Studies ; Sepsis/drug therapy ; Shock, Septic
    Chemical Substances Immunoglobulin M
    Language English
    Publishing date 2021-04-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 632818-0
    ISSN 1557-8615 ; 0883-9441
    ISSN (online) 1557-8615
    ISSN 0883-9441
    DOI 10.1016/j.jcrc.2021.03.015
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: The Roles of Protocols and Protocolization in Improving Outcome From Severe Traumatic Brain Injury.

    Chesnut, Randall M / Temkin, Nancy / Videtta, Walter / Lujan, Silvia / Petroni, Gustavo / Pridgeon, Jim / Dikmen, Sureyya / Chaddock, Kelley / Hendrix, Terence / Barber, Jason / Machamer, Joan / Guadagnoli, Nahuel / Hendrickson, Peter / Alanis, Victor / La Fuente, Gustavo / Lavadenz, Arturo / Merida, Roberto / Sandi Lora, Freddy / Romero, Ricardo /
    Pinillos, Oscar / Urbina, Zulma / Figueroa, Jairo / Ochoa, Marcelo / Davila, Rafael / Mora, Jacobo / Bustamante, Luis / Perez, Carlos / Leiva, Jorge / Carricondo, Carlos / Mazzola, Ana Maria / Guerra, Juan

    Neurosurgery

    2023  

    Abstract: Background and objectives: Our Phase-I parallel-cohort study suggested that managing severe traumatic brain injury (sTBI) in the absence of intracranial pressure (ICP) monitoring using an ad hoc Imaging and Clinical Examination (ICE) treatment protocol ... ...

    Abstract Background and objectives: Our Phase-I parallel-cohort study suggested that managing severe traumatic brain injury (sTBI) in the absence of intracranial pressure (ICP) monitoring using an ad hoc Imaging and Clinical Examination (ICE) treatment protocol was associated with superior outcome vs nonprotocolized management but could not differentiate the influence of protocolization from that of the specific protocol. Phase II investigates whether adopting the Consensus REVised Imaging and Clinical Examination (CREVICE) protocol improved outcome directly or indirectly via protocolization.
    Methods: We performed a Phase-II sequential parallel-cohort study examining adoption of the CREVICE protocol from no protocol vs a previous protocol in patients with sTBI older than 13 years presenting ≤24 hours after injury. Primary outcome was prespecified 6-month recovery. The study was done mostly at public South American centers managing sTBI without ICP monitoring. Fourteen Phase-I nonprotocol centers and 5 Phase-I protocol centers adopted CREVICE. Data were analyzed using generalized estimating equation regression adjusting for demographic imbalances.
    Results: A total of 501 patients (86% male, mean age 35.4 years) enrolled; 81% had 6 months of follow-up. Adopting CREVICE from no protocol was associated with significantly superior results for overall 6-month extended Glasgow Outcome Score (GOSE) (protocol effect = 0.53 [0.11, 0.95], P = .013), mortality (36% vs 21%, HR = 0.59 [0.46, 0.76], P < .001), and orientation (Galveston Orientation and Amnesia Test discharge protocol effect = 10.9 [6.0, 15.8], P < .001, 6-month protocol effect = 11.4 [4.1, 18.6], P < .005). Adopting CREVICE from ICE was associated with significant benefits to GOSE (protocol effect = 0.51 [0.04, 0.98], P = .033), 6-month mortality (25% vs 18%, HR = 0.55 [0.39, 0.77], P < .001), and orientation (Galveston Orientation and Amnesia Test 6-month protocol effect = 9.2 [3.6, 14.7], P = .004). Comparing both groups using CREVICE, those who had used ICE previously had significantly better GOSE (protocol effect = 1.15 [0.09, 2.20], P = .033).
    Conclusion: Centers managing adult sTBI without ICP monitoring should strongly consider protocolization through adopting/adapting the CREVICE protocol. Protocolization is indirectly supported at sTBI centers regardless of resource availability.
    Language English
    Publishing date 2023-12-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 135446-2
    ISSN 1524-4040 ; 0148-396X
    ISSN (online) 1524-4040
    ISSN 0148-396X
    DOI 10.1227/neu.0000000000002777
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  3. Article ; Online: A clinical decision rule to predict intracranial hypertension in severe traumatic brain injury.

    Alali, Aziz S / Temkin, Nancy / Barber, Jason / Pridgeon, Jim / Chaddock, Kelley / Dikmen, Sureyya / Hendrickson, Peter / Videtta, Walter / Lujan, Silvia / Petroni, Gustavo / Guadagnoli, Nahuel / Urbina, Zulma / Chesnut, Randall M

    Journal of neurosurgery

    2018  Volume 131, Issue 2, Page(s) 612–619

    Abstract: Objective: While existing guidelines support the treatment of intracranial hypertension in severe traumatic brain injury (TBI), it is unclear when to suspect and initiate treatment for high intracranial pressure (ICP). The objective of this study was to ...

    Abstract Objective: While existing guidelines support the treatment of intracranial hypertension in severe traumatic brain injury (TBI), it is unclear when to suspect and initiate treatment for high intracranial pressure (ICP). The objective of this study was to derive a clinical decision rule that accurately predicts intracranial hypertension.
    Methods: Using Delphi methods, the authors identified a set of potential predictors of intracranial hypertension and a clinical decision rule a priori by consensus among a group of 43 neurosurgeons and intensivists who have extensive experience managing severe TBI without ICP monitoring. To validate these predictors, the authors used data from a Latin American trial (n = 150; BEST TRIP). To report on the performance of the rule, they calculated sensitivity, specificity, and positive and negative predictive values with 95% confidence intervals. In a secondary analysis, the rule was validated using data from a North American trial (n = 131; COBRIT).
    Results: The final predictors and the clinical decision rule were approved by 97% of participants in the consensus working group. The predictors are divided into major and minor criteria. High ICP would be considered suspected in the presence of 1 major or ≥ 2 minor criteria. Major criteria are: compressed cisterns (CT classification of Marshall diffuse injury [DI] III), midline shift > 5 mm (Marshall DI IV), or nonevacuated mass lesion. Minor criteria are: Glasgow Coma Scale (GCS) motor score ≤ 4, pupillary asymmetry, abnormal pupillary reactivity, or Marshall DI II. The area under the curve for the logistic regression model that contains all the predictors was 0.86. When high ICP was defined as > 22 mm Hg, the decision rule performed with a sensitivity of 93.9% (95% CI 85.0%-98.3%), a specificity of 42.3% (95% CI 31.7%-53.6%), a positive predictive value of 55.5% (95% CI 50.7%-60.2%), and a negative predictive value of 90% (95% CI 77.1%-96.0%). The sensitivity of the clinical decision rule improved with higher ICP cutoffs up to a sensitivity of 100% when intracranial hypertension was defined as ICP > 30 mm Hg. Similar results were found in the North American cohort.
    Conclusions: A simple clinical decision rule based on a combination of clinical and imaging findings was found to be highly sensitive in distinguishing patients with severe TBI who would suffer intracranial hypertension. It could be used to identify patients who require ICP monitoring in high-resource settings or start ICP-lowering treatment in environments where resource limitations preclude invasive monitoring.Clinical trial registration no.: NCT02059941 (clinicaltrials.gov).
    MeSH term(s) Adult ; Brain Injuries, Traumatic/diagnostic imaging ; Brain Injuries, Traumatic/epidemiology ; Clinical Decision-Making/methods ; Double-Blind Method ; Female ; Humans ; Intracranial Hypertension/diagnostic imaging ; Intracranial Hypertension/epidemiology ; Male ; Middle Aged ; Predictive Value of Tests ; Severity of Illness Index ; Young Adult
    Language English
    Publishing date 2018-09-28
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 3089-2
    ISSN 1933-0693 ; 0022-3085
    ISSN (online) 1933-0693
    ISSN 0022-3085
    DOI 10.3171/2018.4.JNS173166
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  4. Article ; Online: Testing the Impact of Protocolized Care of Patients With Severe Traumatic Brain Injury Without Intracranial Pressure Monitoring: The Imaging and Clinical Examination Protocol.

    Chesnut, Randall M / Temkin, Nancy / Videtta, Walter / Lujan, Silvia / Petroni, Gustavo / Pridgeon, Jim / Dikmen, Sureyya / Chaddock, Kelley / Hendrix, Terence / Barber, Jason / Machamer, Joan / Guadagnoli, Nahuel / Hendrickson, Peter / Alanis, Victor / La Fuente, Gustavo / Lavadenz, Arturo / Merida, Roberto / Lora, Freddy Sandi / Romero, Ricardo /
    Pinillos, Oscar / Urbina, Zulma / Figueroa, Jairo / Ochoa, Marcelo / Davila, Rafael / Mora, Jacobo / Bustamante, Luis / Perez, Carlos / Leiva, Jorge / Carricondo, Carlos / Mazzola, Ana Maria / Guerra, Juan

    Neurosurgery

    2022  Volume 92, Issue 3, Page(s) 472–480

    Abstract: Background: Most patients with severe traumatic brain injury (sTBI) in low- or-middle-income countries and surprisingly many in high-income countries are managed without intracranial pressure (ICP) monitoring. The impact of the first published protocol ( ...

    Abstract Background: Most patients with severe traumatic brain injury (sTBI) in low- or-middle-income countries and surprisingly many in high-income countries are managed without intracranial pressure (ICP) monitoring. The impact of the first published protocol (Imaging and Clinical Examination [ICE] protocol) is untested against nonprotocol management.
    Objective: To determine whether patients treated in intensive care units (ICUs) using the ICE protocol have lower mortality and better neurobehavioral functioning than those treated in ICUs using no protocol.
    Methods: This study involved nineteen mostly public South American hospitals. This is a prospective cohort study, enrolling patients older than 13 years with sTBI presenting within 24 h of injury (January 2014-July 2015) with 6-mo postinjury follow-up. Five hospitals treated all sTBI cases using the ICE protocol; 14 used no protocol. Primary outcome was prespecified composite of mortality, orientation, functional outcome, and neuropsychological measures.
    Results: A total of 414 patients (89% male, mean age 34.8 years) enrolled; 81% had 6 months of follow-up. All participants included in composite outcome analysis: average percentile (SD) = 46.8 (24.0) nonprotocol, 56.9 (24.5) protocol. Generalized estimating equation (GEE) used to account for center effects (confounder-adjusted difference [95% CI] = 12.2 [4.6, 19.8], P = .002). Kaplan-Meier 6-month mortality (95% CI) = 36% (30%, 43%) nonprotocol, 25% (19%, 31%) protocol (GEE and confounder-adjusted hazard ratio [95% CI] = .69 [.43, 1.10], P = .118). Six-month Extended Glasgow Outcome Scale for 332 participants: average Extended Glasgow Outcome Scale score (SD) = 3.6 (2.6) nonprotocol, 4.7 (2.8) protocol (GEE and confounder-adjusted and lost to follow-up-adjusted difference [95% CI] = 1.36 [.55, 2.17], P = .001).
    Conclusion: ICUs managing patients with sTBI using the ICE protocol had better functional outcome than those not using a protocol. ICUs treating patients with sTBI without ICP monitoring should consider protocolization. The ICE protocol, tested here and previously, is 1 option.
    MeSH term(s) Humans ; Male ; Adult ; Female ; Brain Injuries ; Intracranial Pressure ; Prospective Studies ; Brain Injuries, Traumatic/diagnostic imaging ; Brain Injuries, Traumatic/therapy ; Monitoring, Physiologic/methods
    Language English
    Publishing date 2022-12-12
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 135446-2
    ISSN 1524-4040 ; 0148-396X
    ISSN (online) 1524-4040
    ISSN 0148-396X
    DOI 10.1227/neu.0000000000002251
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  5. Article ; Online: Development of a Severe Traumatic Brain Injury Consensus-Based Treatment Protocol Conference in Latin America.

    Hendrickson, Peter / Pridgeon, James / Temkin, Nancy R / Videtta, Walter / Petroni, Gustavo / Lujan, Silvia / Guadagnoli, Nahuel / Urbina, Zulma / Pahnke, Perla Blanca / Godoy, Daniel / Pinero, Gustavo / Lora, Freddy Sandi / Aguilera, Sergio / Rubiano, Andres M / Morejon, Caridad Soler / Jibaja, Manuel / Lopez, Hubiel / Romero, Ricardo / Dikmen, Sureyya /
    Chaddock, Kelley / Chesnut, Randall M

    World neurosurgery

    2017  Volume 110, Page(s) e952–e957

    Abstract: Background: Severe traumatic brain injury (sTBI) is a significant global health problem disproportionately affecting low- and middle-income countries (LMICs). Management of intracranial hypertension in sTBI is crucial to survival and optimal recovery. ... ...

    Abstract Background: Severe traumatic brain injury (sTBI) is a significant global health problem disproportionately affecting low- and middle-income countries (LMICs). Management of intracranial hypertension in sTBI is crucial to survival and optimal recovery. Practitioners in high-income countries routinely use intracranial pressure (ICP) monitors although their usefulness has been questioned. ICP monitors are usually unavailable in LMICs. No consensus-based/tested protocols or literature exists for sTBI treatment without ICP monitoring.
    Methods: Investigators developed serial SurveyMonkey surveys for Latin American neurointensivists and neurosurgeons to determine current practice. These clinicians had extensive routine ongoing experience in sTBI without ICP monitoring. Surveys were administered and analyzed before/during/after a 2015 Buenos Aires consensus conference. Investigators identified areas of convergence blinded from colleagues' responses. A 47-clinician task force, representing 15 countries, who routinely manage patients with sTBI without monitors developed consensus-based treatment guidelines during a 3-day facilitated conference.
    Results: Elements were added to the protocol at an 80% agreement threshold. Follow-on surveys resolved remaining elements to 97% agreement. The protocol addresses both tapering (on improvement) and neuroworsening. Staged treatment options were identified, plus unique clinical practice issues. This process introduced a research method to a large multidisciplinary group of LMIC clinicians. This report describes the process used to develop an LMIC-specific protocol that is transferable to other diseases/injuries. The protocol is being tested in 5 LMICs.
    Conclusions: We derived consensus-based guidelines for sTBI treatment without ICP monitoring, and introduced a research method to a large multidisciplinary group of LMIC clinicians naive to such methods.
    MeSH term(s) Brain Injuries, Traumatic/complications ; Brain Injuries, Traumatic/epidemiology ; Clinical Protocols/standards ; Consensus ; Health Surveys ; Humans ; Intracranial Hypertension/epidemiology ; Intracranial Hypertension/etiology ; Intracranial Hypertension/therapy ; Latin America/epidemiology ; Monitoring, Physiologic
    Language English
    Publishing date 2017-12-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2534351-8
    ISSN 1878-8769 ; 1878-8750
    ISSN (online) 1878-8769
    ISSN 1878-8750
    DOI 10.1016/j.wneu.2017.11.142
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    Zs.A 1159: Show issues Location:
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  6. Article ; Online: Consensus-Based Management Protocol (CREVICE Protocol) for the Treatment of Severe Traumatic Brain Injury Based on Imaging and Clinical Examination for Use When Intracranial Pressure Monitoring Is Not Employed.

    Chesnut, Randall M / Temkin, Nancy / Videtta, Walter / Petroni, Gustavo / Lujan, Silvia / Pridgeon, Jim / Dikmen, Sureyya / Chaddock, Kelley / Barber, Jason / Machamer, Joan / Guadagnoli, Nahuel / Hendrickson, Peter / Aguilera, Sergio / Alanis, Victor / Bello Quezada, Manuel Enrique / Bautista Coronel, Ermitaño / Bustamante, Luis Alberto / Cacciatori, Armando C / Carricondo, Carlos Javier /
    Carvajal, Felipe / Davila, Rafael / Dominguez, Mario / Figueroa Melgarejo, Jairo Antonio / Fillipi, Maria Martha / Godoy, Daniel A / Gomez, Delia Cristina / Lacerda Gallardo, Angel J / Guerra Garcia, Juan Antonio / Zerain, Gustavo la Fuente / Lavadenz Cuientas, Luis Arturo / Lequipe, Cecilio / Grajales Yuca, Gerardo Vicente / Jibaja Vega, Manuel / Kessler, Michael Eduardo / López Delgado, Hubiel J / Sandi Lora, Freddy / Mazzola, Ana Maria / Maldonado, Roberto Merida / Mezquia de Pedro, Natascha / Martínez Zubieta, J Ricardo / Mijangos Méndez, Julio C / Mora, Jacobo / Ochoa Parra, Johnny Marcelo / Pahnke, Perla B / Paranhos, Jorge / Piñero, Gustavo R / Rivadeneira Pilacuán, Francisco A / Mendez Rivera, Mario Napoleon / Romero Figueroa, Ricardo Luis / Rubiano, Andres M / Saraguro Orozco, Alexandra Matilde / Silesky Jiménez, Juan Ignacio / Silva Naranjo, Luis / Soler Morejon, Caridad / Urbina, Zulma

    Journal of neurotrauma

    2020  Volume 37, Issue 11, Page(s) 1291–1299

    Abstract: Globally, intracranial pressure (ICP) monitoring use in severe traumatic brain injury (sTBI) is inconsistent and susceptible to resource limitations and clinical philosophies. For situations without monitoring, there is no published comprehensive ... ...

    Abstract Globally, intracranial pressure (ICP) monitoring use in severe traumatic brain injury (sTBI) is inconsistent and susceptible to resource limitations and clinical philosophies. For situations without monitoring, there is no published comprehensive management algorithm specific to identifying and treating suspected intracranial hypertension (SICH) outside of the one ad hoc Imaging and Clinical Examination (ICE) protocol in the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure (BEST:TRIP) trial. As part of an ongoing National Institutes of Health (NIH)-supported project, a consensus conference involving 43 experienced Latin American Intensivists and Neurosurgeons who routinely care for sTBI patients without ICP monitoring, refined, revised, and augmented the original BEST:TRIP algorithm. Based on BEST:TRIP trial data and pre-meeting polling, 11 issues were targeted for development. We used Delphi-based methodology to codify individual statements and the final algorithm, using a group agreement threshold of 80%. The resulting CREVICE (Consensus REVised ICE) algorithm defines SICH and addresses both general management and specific treatment. SICH treatment modalities are organized into tiers to guide treatment escalation and tapering. Treatment schedules were developed to facilitate targeted management of disease severity. A decision-support model, based on the group's combined practices, is provided to guide this process. This algorithm provides the first comprehensive management algorithm for treating sTBI patients when ICP monitoring is not available. It is intended to provide a framework to guide clinical care and direct future research toward sTBI management. Because of the dearth of relevant literature, it is explicitly consensus based, and is provided solely as a resource (a "consensus-based curbside consult") to assist in treating sTBI in general intensive care units in resource-limited environments.
    MeSH term(s) Brain Injuries, Traumatic/diagnostic imaging ; Brain Injuries, Traumatic/physiopathology ; Clinical Protocols/standards ; Consensus ; Delphi Technique ; Humans ; Intracranial Hypertension/diagnostic imaging ; Intracranial Hypertension/physiopathology ; Intracranial Pressure/physiology ; Monitoring, Physiologic/standards ; Neurosurgeons/standards ; Severity of Illness Index ; Treatment Outcome
    Language English
    Publishing date 2020-03-04
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 645092-1
    ISSN 1557-9042 ; 0897-7151
    ISSN (online) 1557-9042
    ISSN 0897-7151
    DOI 10.1089/neu.2017.5599
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