Balanced Solution Versus Saline in Intensive Care Study
Phase 3
Completed
- Conditions
- Critical IllnessAcute Kidney Injury
- Interventions
- Registration Number
- NCT02875873
- Lead Sponsor
- Hospital do Coracao
- Brief 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
- Detailed Description
Pragmatic, multicenter, 2x2 factorial randomized study. Severe patients admitted to the ICU at moderate to high risk for death or acute kidney injury will be randomly allocated to receive a balanced crystalloid solution (Plasma-Lyte®) or 0.9% saline and to receive crystalloids by rapid bolus infusion (999 mL/h) or slow infusion (333 mL/h) whenever plasma expansion is needed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11075
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Plasma-Lyte, Slow Infusion Slow infusion speed Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. Plasma-Lyte, Fast Infusion Fast Infusion Speed Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. Saline 0.9%, Fast Infusion Saline 0.9% Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. Saline 0.9%, Slow Infusion Saline 0.9% Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. Saline 0.9%, Fast Infusion Fast Infusion Speed Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. Saline 0.9%, Slow Infusion Slow infusion speed Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. Plasma-Lyte, Slow Infusion Plasma-Lyte Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. Plasma-Lyte, Fast Infusion Plasma-Lyte Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h.
- Primary Outcome Measures
Name Time Method Mortality 90 days
- Secondary Outcome Measures
Name Time Method Renal Injury (KDIGO equal or greater than 2) Days 3 and 7 Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores) Days 3 and 7 Renal failure requiring renal replacement therapy 90 days Mechanical ventilation free days 28 days
Trial Locations
- Locations (1)
Alexandre Biasi Cavalcanti
🇧🇷São Paulo, SP, Brazil