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OPTImized Restrictive Strategy Targeting Non-Resuscitative FLUIDs in Septic Shock: Pilot Study.

NCT04947904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-10

No results posted yet for this study

Summary

Intravenous fluids are one of the keystones in the initial management of patients with septic shock, but they inevitably lead to a fluid overload, which is associated with poor outcome.

So far no studies have evaluated the interest of a restrictive strategy for managing fluid intake targeting all non-resuscitative fluids (fluids for maintenance and drug dilution as well as nutrition) and especially the impact of this restrictive strategy on fluid overload.

The hypothesis of this research is that an optimised restrictive strategy targeting all non-resuscitative fluids in patients hospitalised in the intensive care unit for septic shock, will have an impact on fluid balance in these patients.

Conditions

  • Septic Shock
  • Electrolyte and Fluid Balance Conditions

Interventions

OTHER

Reduction of the patient's fluid intake during the first 7 days

The volume of fluids infused to the patient will be reduced by the doctor in charge of the patient for the first 7 days of the patient's stay in the intensive care unit according to a protocol with instructions to reduce fluid intake as far as possible in terms of maintenance fluids, dilution of medication and artificial nutrition. This protocol will be begun immediately following the patient's inclusion on Day 1 and pursued for 7 days after inclusion (i.e. from Day 1 - to Day 7). The fluid restriction strategy does not involve the administration of any medication (i.e. diuretics). A clinical pharmacist will help the intensive care teams apply the fluid restriction protocol with a daily check. If the restrictive strategy leads to hypovolemia and / or a electrolyte anomaly (sodium, potassium, chloride, etc.), the physician in charge will be authorised to treat these anomalies in conformance with the protocol recommendations.

Sponsors & Collaborators

  • University Hospital, Montpellier

    collaborator OTHER

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2023-01-27
Completion
2023-02-25

Countries

  • France

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 NCT04947904 on ClinicalTrials.gov