Preventive Versus Curative Treatment of Fluid Overload

NCT04050007 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2024-01-17

No results posted yet for this study

Summary

Fluid overload is associated with a poor prognosis in critically ill patients, especially during weaning from mechanical ventilation as it may promote weaning induced pulmonary edema. Previous data suggest that early administration of diuretics ("preventive depletion") could shorten the duration of mechanical ventilation. However, this strategy may expose patients to a risk of metabolic complications. On the other hand, initiating fluid removal only in case of weaning induced pulmonary edema (curative depletion) may reduce the risk of metabolic complications, but prolong the duration of mechanical ventilation. Currently, there is no recommendation for a preventive or curative use of diuretics during weaning. There is therefore an equipoise on the timing of initiation of diuretics during weaning from mechanical ventilation.

Conditions

  • Respiratory Insufficiency

Interventions

OTHER

Preventive initiation of fluid removal

Preventive initiation of fluid removal will be started right after the randomization with intravenous diuretics according to a predefined algorithm based on the urine output every three hours. The weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines

OTHER

Curative initiation of fluid removal

The initiation of fluid removal will be considered by the attending physician only in case of failure to the spontaneous breathing trial with a clinical suspicion of weaning induced pulmonary edema. The weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2024-03-01
Completion
2024-03-01

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 NCT04050007 on ClinicalTrials.gov