Preventive Versus Curative Treatment of Fluid Overload
PCT-Fluid
Effect of a Systematic Preventive Versus Curative Strategy of Fluid Removal on the Weaning of Mechanical Ventilation
2 other identifiers
interventional
410
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedJanuary 17, 2024
January 1, 2024
4.1 years
August 6, 2019
January 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of weaning from mechanical ventilation
Time elapsed between the day of randomization and the day of successful extubation (patient alive without reintubation 7 days after extubation)
28 days
Secondary Outcomes (13)
Percentage of patients with metabolic complications
28 days
Percentage of patients with hemodynamic complications
28 days
Daily and cumulated fluid balance
28 days
Rate of patients who failed the first spontaneous breathing trial
28 days
Rate of reintubation
7 days
- +8 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALPreventive initiation of fluid removal
2
OTHERCurative initiation of fluid removal
Interventions
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
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
Eligibility Criteria
You may qualify if:
- age\>18
- intubation and mechanical ventilation \>= 24 hours
- cumulative fluid balance judged positive or increase in body weight since admission
- clinical stability as defined by: 4.1. stable oxygenation (SpO2 ≥ 90 % with FiO2 ≤ 50 % and positive end-expiratory pressure (PEEP) ≤ 8 cm H2O) 4.2. stable hemodynamics (no pressors, no fluid expansion within the last 12 hours) 4.3. stopped or decreased sedation within the last 48 hours and stable neurologic state.
- temperature \>36,0 ◦C and \< 39◦C
- consent signed by the patient or next of kin or emergency procedure
You may not qualify if:
- extracorporal membrane oxygenation
- pregnancy or breastfeeding
- allergy to furosemide, sulfamides or spironolactone
- tracheotomy
- hydrocephaly
- acute right ventricle failure
- cardiac arrest with estimated poor prognosis
- already enrolled in an interventional study on weaning from mechanical ventilation
- Guillain Barre, myasthenia crisis
- planned extubation on the day
- criteria of clinical stability (as described above) present since more than 24 hours
- natremia \> 150 mEq/L, kaliemia \< 3.5 mEq/L, metabolic alkalosis with pH\>7.5
- administration of iodinated contrast within the last 6 hours
- ongoing or planned use of artificial kidney within the next 48 hours
- no affiliation to the health insurance system
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GH Pitié Salpêtrière - Charles Foix
Paris, 75013, France
Related Publications (1)
Dres M, Estellat C, Baudel JL, Beloncle F, Cousty J, Galbois A, Guerin L, Labbe V, Labro G, Lebut J, Mira JP, Prat G, Quenot JP, Dessap A; Reseau Europeen de Recherche en Ventilation Artificielle (REVA) research network. Comparison of a preventive or curative strategy of fluid removal on the weaning of mechanical ventilation: a study protocol for a multicentre randomised open-label parallel-group trial. BMJ Open. 2021 Aug 16;11(8):e048286. doi: 10.1136/bmjopen-2020-048286.
PMID: 34400454DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 8, 2019
Study Start
February 1, 2020
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
January 17, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.