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Updated: Nov 27, 2025

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

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Published on: January 16, 2019

Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).

Lucas Petri Damiani¹, Alexandre Biasi Cavalcanti¹, Rodrigo Santos Biondi²

¹Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.

Revista Brasileira De Terapia Intensiva

|December 2, 2020

Summary

This summary is machine-generated.

The Balanced Solutions versus Saline in Intensive Care Study (BaSICS) will compare Plasma-Lyte 148 and 0.9% saline in critically ill patients. This trial also examines fluid infusion speeds to determine optimal patient outcomes.

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Area of Science:

Critical Care Medicine
Clinical Trials
Fluid Management

Background:

Critically ill patients often receive intravenous fluids.
The choice of fluid (balanced solutions vs. saline) and infusion speed can impact patient outcomes.
Standardized statistical analysis plans are crucial for rigorous clinical trial execution.

Purpose of the Study:

To detail the first version of the statistical analysis plan for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).
To outline the methodology for comparing Plasma-Lyte 148 and 0.9% saline in critically ill patients.
To define the analysis for fluid challenge infusion speeds (slow vs. rapid).

Main Methods:

Multicenter factorial randomized controlled trial.
Blinded assessment of fluid type; unblinded but blinded analysis of infusion speed.
Mixed-effects Cox proportional hazard models (frailty models) for primary endpoint analysis.

Main Results:

Primary endpoint: 90-day mortality.
Secondary endpoints include renal replacement therapy, acute renal failure, organ dysfunction, and mechanical ventilation-free days.
Statistical models will be adjusted for age, organ dysfunction, and admission type.

Conclusions:

This document presents the initial statistical analysis plan for the BaSICS trial.
The plan will guide the analysis of primary and secondary outcomes.
Ensures a rigorous and transparent approach to evaluating fluid management strategies in intensive care.