Clinical trial NCT05612490: Furosemide Stress Test to Predict Successful Liberation From RRT
Official title: Evaluation of the Furosemide Stress Test to Predict Successful Liberation From Renal Replacement Therapy in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: Renal replacement therapy
Acute Kidney Injury
Furosemide Stress Test
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients receiving continuous RRT for AKI

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful liberation of RRT within 72 hours after FST
timeFrame: within 72 hours
Secondary outcomes:
measure: Successful liberation of RRT at ICU discharge
timeFrame: At time of ICU discharge, assessed up to 90 days post inclusion
measure: Successful liberation of RRT at hospital discharge
timeFrame: At time of hospital discharge, assessed up to 90 days post inclusion
measure: Adverse events associated with the intervention
timeFrame: within 6 hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Antoine Schneider, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.