FST-RRT: Furosemide Stress Test to Predict Successful Liberation From RRT

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05612490
Collaborator
(none)
60
19.9

Study Details

Study Description

Brief Summary

The proposed study will evaluate if a standardised dose of furosemide administered in the 12 hours after RRT liberation can predict successful liberation in critically ill patients. The dose that will be administered is in accordance with the prescribing information.

Condition or Disease Intervention/Treatment Phase
  • Drug: Furosemide stress test

Detailed Description

Response to furosemide administration is commonly used in clinical practice to assess a patient's potential for RRT liberation. However, this administration is not standardized and practices varies greatly. Rapid recognition of unsuccessful RRT liberation is crucial to avoid further complications such as fluid overload or acid-base and electrolyte disorders. The FST corresponds to the intravenous administration of 1 mg/kg (1.5 mg/kg in previously exposed patients) of furosemide and the assessment of resulting diuresis in the following two hours. FST is able to predict progression from AKI stage I and II to stage III with a high sensitivity (87.1%) and specificity (84.1%), area under the ROC curve 0.87. However, the ability of FST to predict RRT liberation has never been formally assessed.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluation of the Furosemide Stress Test to Predict Successful Liberation From Renal Replacement Therapy in Critically Ill Patients
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Critically ill patients undergoing RRT

Patients admitted to participating ICU and receiving renal replacement therapy.

Drug: Furosemide stress test
The FST corresponds to the intravenous single-dose administration of 1 mg/kg (1.5 mg/kg in previously exposed patients) of furosemide and the assessment of resulting diuresis in the following two hours. In the 12 hours following the first RRT liberation, a FST will be performed. The test will be considered positive if urinary output is ≥200 mL in the two hours following furosemide administration.
Other Names:
  • FST
  • Outcome Measures

    Primary Outcome Measures

    1. Successful liberation of RRT within 72 hours after FST [within 72 hours]

      No renal replacement therapy administered

    Secondary Outcome Measures

    1. Successful liberation of RRT at ICU discharge [At time of ICU discharge, assessed up to 90 days post inclusion]

      No renal replacement therapy administered

    2. Successful liberation of RRT at hospital discharge [At time of hospital discharge, assessed up to 90 days post inclusion]

      No renal replacement therapy administered

    3. Adverse events associated with the intervention [within 6 hours]

      (electrolyte disturbances, hypotension)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Receiving continuous RRT for AKI

    • Having an indwelling urinary catheter

    • Clinical decision by physician in charge to attempt RRT liberation (first attempt)

    • lnformed consent signed by the patient himself / legal representative or authorization received from independent physician

    Exclusion Criteria:
    • Electrolyte disturbances or hemodynamic instability precluding the use of furosemide (sodium > 155 mmol/L and/or potassium < 3.0 mmol/L and/or metabolic alkalosis > 7.50 and/or mean arterial pressure < 60 mmHg)

    • Furosemide allergy

    • Urine output ≥ 100 mL/h for at least two hours

    • Prior FST during the ICU stay

    • Known end-stage chronic renal disease at ICU admission

    • Withdrawal of life support decision taken before inclusion

    • Patient already participating in conflicting research study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Vaudois

    Investigators

    • Principal Investigator: Antoine Schneider, MD PhD, Centre Hospitalier Universitaire Vaudois

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antoine Schneider, Doctor, Centre Hospitalier Universitaire Vaudois
    ClinicalTrials.gov Identifier:
    NCT05612490
    Other Study ID Numbers:
    • 2022-01826
    First Posted:
    Nov 10, 2022
    Last Update Posted:
    Nov 10, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Antoine Schneider, Doctor, Centre Hospitalier Universitaire Vaudois
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2022