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Balanced Solution Versus Saline in Intensive Care Study

NCT02875873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11075

Last updated 2021-04-19

No results posted yet for this study

Summary

A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients

Conditions

Interventions

DRUG

Plasma-Lyte

Plasma-Lyte will be used for fluid expansion and maintenance

DRUG

Saline 0.9%

Saline 0.9% will be used for fluid expansion and maintenance

OTHER

Slow infusion speed

Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. NOTE: This intervention will not be blinded.

OTHER

Fast Infusion Speed

Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. NOTE: This intervention will not be blinded.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alexandre B Cavalcanti, MD, PhD · Hospital do Coracao

  • Fernando G Zampieri, MD · Hospital do Coracao

  • Nilton Brandao, MD, PhD · Hospital Moinhos de Vento

  • Flávia R Machado, MD, PhD · Universidade Federal de São Paulo, UNIFESP

  • Rodrigo S Biondi, MD · Instituto de Cardiologia do Distrito Federal, ICDF

  • Flávio G Rezende de Freitas, MD, PhD · Universidade Federal de São Paulo, Departamento de Cirurgia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-27
Primary Completion
2020-03-02
Completion
2021-02-28

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875873 on ClinicalTrials.gov