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

NCT03668236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1554

Last updated 2025-02-24

Study results available
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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.

Conditions

  • Septic Shock

Interventions

DRUG

Isotonic crystalloids

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Centre for Research in Intensive Care (CRIC)

    collaborator OTHER

  • Scandinavian Critical Care Trials Group

    collaborator OTHER

  • Anders Perner, MD, PhD

    lead OTHER

Principal Investigators

  • Tine Sylvest Meyhoff, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2022-02-14
Completion
2022-11-16

Countries

  • Belgium
  • Czechia
  • Denmark
  • Italy
  • Norway
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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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 NCT03668236 on ClinicalTrials.gov