Furosemide Stress Test to Predict Successful Liberation From RRT

NCT05612490 | Completed DMC FDA Drug

• 1 other identifier: 2022-01826
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Renal replacement therapy; Acute Kidney Injury; Furosemide Stress Test

Outcome Measures

Primary Outcomes (1)

• Successful liberation of RRT within 72 hours after FST

  No renal replacement therapy administered

  within 72 hours

Secondary Outcomes (3)

• Successful liberation of RRT at ICU discharge

  At time of ICU discharge, assessed up to 90 days post inclusion

• Successful liberation of RRT at hospital discharge

  At time of hospital discharge, assessed up to 90 days post inclusion

• Adverse events associated with the intervention

  within 6 hours

Study Arms (1)

Critically ill patients undergoing RRT

Patients admitted to participating ICU and receiving renal replacement therapy.

Drug: Furosemide stress test

Interventions

Furosemide stress test DRUG

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.

Also known as: FST

Critically ill patients undergoing RRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ICU patients receiving continuous RRT for AKI

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient already participating in conflicting research study
• Patient having already participated in this current study
• Any other contraindication of furosemide

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.

  PMID: 24053972 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sample at D0, D1, D2 and D3 and on RRT restart (if applicable)

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Antoine Schneider, MD PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: January 17, 2023
• Primary Completion: June 4, 2025
• Study Completion: July 9, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)