NCT02875873: BaSICS

Balanced Solution Versus Saline in Intensive Care Study

Completed Phase 3 Last updated 19 April 2021

What this trial tests

Phase 3 trial testing Plasma-Lyte in Critical Illness in 11,075 participants. Completed in 28 February 2021.

Timeline

27 May 2017

Primary endpoint
2 March 2020

28 February 2021

Quick facts

Lead sponsor	Hospital do Coracao
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	11,075
Start date	27 May 2017
Primary completion	2 March 2020
Estimated completion	28 February 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Plasma-Lyte — full drug profile →
• Saline 0.9% — full drug profile →
• Slow infusion speed
• Fast Infusion Speed

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

Hospital do Coracao

Who can join

18 and older, any sex, with Critical Illness or Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Controversies in acute kidney injury: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference.
   Ostermann M, Bellomo R, Burdmann EA, Doi K, et al · · 2020 · cited 384× · PMID 32709292 · DOI 10.1016/j.kint.2020.04.020
2. Perioperative Acute Kidney Injury.
   Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968
3. Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial.
   Zampieri FG, Machado FR, Biondi RS, Freitas FGR, et al · · 2021 · cited 145× · PMID 34375394 · DOI 10.1001/jama.2021.11684
4. Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults: A Secondary Exploratory Analysis of the BaSICS Clinical Trial.
   Zampieri FG, Machado FR, Biondi RS, Freitas FGR, et al · · 2022 · cited 47× · PMID 35349397 · DOI 10.1164/rccm.202111-2484oc
5. Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial.
   Zampieri FG, Azevedo LCP, Corrêa TD, Falavigna M, et al · · 2017 · cited 40× · PMID 28651514
6. Hemodynamic support in the early phase of septic shock: a review of challenges and unanswered questions.
   Lesur O, Delile E, Asfar P, Radermacher P. · · 2018 · cited 36× · PMID 30374729 · DOI 10.1186/s13613-018-0449-8
7. Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial.
   Zampieri FG, Machado FR, Biondi RS, Freitas FGR, et al · · 2021 · cited 35× · PMID 34547081 · DOI 10.1001/jama.2021.11444
8. Buffered solutions versus 0.9% saline for resuscitation in critically ill adults and children.
   Antequera Martín AM, Barea Mendoza JA, Muriel A, Sáez I, et al · · 2019 · cited 28× · PMID 31334842 · DOI 10.1002/14651858.cd012247.pub2