CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,554 enrolled
Drug / intervention
Isotonic crystalloidsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03668236
NCT03668236Phase 4Completed

The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

Anders Perner, MD, PhD·interventional·Posted Sep 12, 2018·Updated Feb 24, 2025

In Brief

A Phase 4 clinical trial evaluating Isotonic crystalloids for Septic Shock. Completed, enrolled 1,554 participants across 31 sites in 8 countries.

Detailed Summary

The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesBelgium, Czechia, Denmark, Italy, Norway, Sweden, Switzerland, United Kingdom

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 12, 2018
Enrollment StartNov 27, 2018
Primary CompletionFeb 14, 2022
Study CompletionNov 16, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.8 years ago

Interventions

Isotonic crystalloidsdrug

Types of fluid to be used in both intervention groups: * IV fluids given for circulatory impairment: Only isotonic crystalloids are to be used as per the Scandinavian guideline for fluid resuscitation * Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used * Fluids used for dehydration: Water or isotonic glucose should be used * Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency, including water in the case of severe hypernatremia * Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy