Effects of IV fluid restriction according to site-specific intensity of standard fluid treatment-protocol.
Acta Anaesthesiol Scand
; 68(7): 975-982, 2024 Aug.
Article
em En
| MEDLINE
| ID: mdl-38576165
ABSTRACT
BACKGROUND:
Variation in usual practice in fluid trials assessing lower versus higher volumes may affect overall comparisons. To address this, we will evaluate the effects of heterogeneity in treatment intensity in the Conservative versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care trial. This will reflect the effects of differences in site-specific intensities of standard fluid treatment due to local practice preferences while considering participant characteristics.METHODS:
We will assess the effects of heterogeneity in treatment intensity across one primary (all-cause mortality) and three secondary outcomes (serious adverse events or reactions, days alive without life support and days alive out of hospital) after 90 days. We will classify sites based on the site-specific intensity of standard fluid treatment, defined as the mean differences in observed versus predicted intravenous fluid volumes in the first 24 h in the standard-fluid group while accounting for differences in participant characteristics. Predictions will be made using a machine learning model including 22 baseline predictors using the extreme gradient boosting algorithm. Subsequently, sites will be grouped into fluid treatment intensity subgroups containing at least 100 participants each. Subgroups differences will be assessed using hierarchical Bayesian regression models with weakly informative priors. We will present the full posterior distributions of relative (risk ratios and ratios of means) and absolute differences (risk differences and mean differences) in each subgroup.DISCUSSION:
This study will provide data on the effects of heterogeneity in treatment intensity while accounting for patient characteristics in critically ill adult patients with septic shock. REGISTRATIONS The European Clinical Trials Database (EudraCT) 2018-000404-42, ClinicalTrials. gov NCT03668236.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Choque Séptico
/
Hidratação
Limite:
Humans
Idioma:
En
Revista:
Acta Anaesthesiol Scand
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Dinamarca