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Available online 17 March 2025
Mortality time frame variability in septic shock clinical trials: A systematic review
Variabilidad de lapsos de mortalidad en ensayos clínicos de choque séptico: revisión sistemática
Andres Lasernaa,b,, John A. Cuencaa,c,, Peyton Martina, Cosmo Fowlera, Julian Barahona-Corread, Nirmala Manjappachara, Clara Fowlere, Maria A. Lopez-Olivof, Marcio Borgesg, Charles L. Sprungh, Joseph L. Natesa,
Corresponding author
jlnates@mdanderson.org

Corresponding author.
a Department of Critical Care Medicine, Division of Anesthesiology, Critical Care, and Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, United States
b Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, California, United States
c Texas Institute of Graduate Medical Education and Research (TIGMER), University of Incarnate Word, San Antonio, Texas, United States
d Department of Internal Medicine, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogota, Colombia
e Research Services and Assessment, Research Medical Library, The University of Texas MD Anderson Cancer Center, Houston, TX, United States
f Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States
g Multidisciplinary Sepsis Unit, ICU, Son Llàtzer University Hospital, Balearic, Palma de Mallorca, Spain
h Department of Anesthesiology, Critical Care Medicine and Pain Medicine, Hadassah Medical Organization and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel
Received 07 August 2024. Accepted 06 February 2025
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Abstract
Objective

We sought to delineate the mortality outcome time frames reported in septic shock randomized control trials (RCTs).

Design

Systematic review of PubMed, EMBASE, and the Cochrane Database of Systematic Reviews.

Setting

Intensive care units.

Participants

Studies that included adult patients with septic shock.

Interventions

Any type of intervention.

Main variables of interest

Information about the study, specific patient population, type of study intervention, specific intervention, and number of patients. Mortality time frames were analyzed for geographical differences and changes over time.

Results

The search yielded 2660 unique citations. After screening, 132 eligible studies were identified. A total of 234 mortality time frames were collected from the included studies, of which 15 timeframes were unique. The most frequently reported time frame was 28-day mortality (n = 98, 74% of trials), followed by hospital mortality (n = 35, 27%), ICU mortality (n = 30, 23%), and 90-day mortality (n = 29, 22%). The most reported mortality time frame was 28 days in studies from every continent except Africa. The studies published between 2008 and 2013 (25%) more frequently reported hospital and ICU mortality combination than studies published between 2014 and 2019 (11.4%) (P = 0.043).

Conclusions

There was considerable variability in the mortality time frames reported in ICU-based septic shock trials. This variability may lead to under or overestimation of the problem, overlooking the effectiveness of the interventions studied, and further limiting the application of trials and their pooling in meta-analyses. A consensus regarding time frame reporting in septic shock trials is long overdue.

Keywords:
Septic shock
Randomized controlled trials
Mortality
Systematic review
Abbreviations:
ICU
IF
IQR
RCTs
Resumen
Objetivo

Delinear los lapsos de tasas de mortalidad reportados en ensayos clínicos aleatorizados (ECA) sobre choque séptico.

Diseño

Revisión sistemática de PubMed, EMBASE y la Base de Datos Cochrane de Revisiones Sistemáticas.

Ámbito

Unidades de cuidados intensivos (UCI).

Pacientes o participantes

Estudios de adultos con choque séptico.

Intervenciones

Cualquier intervención.

Variables de interés principales

Población, tipo de intervención y número de pacientes. Se analizaron los lapsos de mortalidad en busca de diferencias geográficas y cambios a lo largo del tiempo.

Resultados

Se encontraron 2660 citas únicas. Después de la selección, se identificaron 132 estudios elegibles. Se recopilaron 234 lapsos de mortalidad de los estudios incluidos, 15 fueron únicos. El lapso de mortalidad reportado con mayor frecuencia fue la mortalidad a 28 días (n = 98, 74% de los ensayos), seguida de la mortalidad hospitalaria (n = 35, 27%), la mortalidad UCI (n = 30, 23%) y la mortalidad a 90 días (n = 29, 22%). El lapso de mortalidad más reportado fue el de 28 días en los estudios de todos los continentes, excepto África. Los estudios publicados entre 2008 y 2013 (25%) informaron con mayor frecuencia la combinación de mortalidad hospitalaria y en la UCI que los publicados entre 2014 y 2019 (11%) (P = 0,043).

Conclusiones

Se halló una variabilidad considerable en los lapsos de mortalidad reportados en los ensayos de choque séptico. Esta variabilidad puede llevar a una subestimación o sobrestimación del problema, pasando por alto la efectividad de las intervenciones estudiadas y limitando aún más la aplicación de los ensayos y su agrupación en metanálisis.

Palabras clave:
Choque séptico
Ensayos clínicos aleatorizados
Mortalidad
Revisión sistemática

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