Furosemide Stress Test to Predict Successful Liberation From RRT

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Drug: Furosemide stress test

• Registration Number: NCT05612490
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

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 Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-10
• Study Start: 2023-01-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-05-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Receiving continuous or intermittent RRT for AKI
• Having an indwelling urinary catheter
• Clinical decision by physician in charge to attempt RRT liberation
• 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)
• Known furosemide allergy
• Urine output ≥ 100 mL/h for at least two hours
• Recent (< 24 hours) FST
• Known end-stage chronic renal disease at ICU admission
• Withdrawal of life support decision taken before inclusion
• Patient already participating in conflicting research study
• Patient having already participated in this current study
• Any other contraindication of furosemide

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients undergoing RRT	Furosemide stress test	Patients admitted to participating ICU and receiving renal replacement therapy.

Primary Outcome Measures

Name	Time	Method
Successful liberation of RRT within 72 hours after FST	within 72 hours	No renal replacement therapy administered

Secondary Outcome Measures

Name	Time	Method
Successful liberation of RRT at hospital discharge	At time of hospital discharge, assessed up to 90 days post inclusion	No renal replacement therapy administered
Successful liberation of RRT at ICU discharge	At time of ICU discharge, assessed up to 90 days post inclusion	No renal replacement therapy administered
Adverse events associated with the intervention	within 6 hours	(electrolyte disturbances, hypotension)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland