Furosemide Stress Test to Predict Successful Liberation From RRT

Acute Kidney Injury Clinical Trial

— FST-RRT  

Official title:

Evaluation of the Furosemide Stress Test to Predict Successful Liberation From Renal Replacement Therapy in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612490
• Other study ID #: 2022-01826
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Antoine schneider, MD PhD
• Phone: +41795561902
• Email: antoine.scheider[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

• 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

• Any other contraindication of furosemide

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful liberation of RRT within 72 hours after FST	No renal replacement therapy administered	within 72 hours
Secondary	Successful liberation of RRT at ICU discharge	No renal replacement therapy administered	At time of ICU discharge, assessed up to 90 days post inclusion
Secondary	Successful liberation of RRT at hospital discharge	No renal replacement therapy administered	At time of hospital discharge, assessed up to 90 days post inclusion
Secondary	Adverse events associated with the intervention	(electrolyte disturbances, hypotension)	within 6 hours