Furosemide Stress Test to Predict Successful Liberation From RRT

Overview

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.

Full Title of Study: “Evaluation of the Furosemide Stress Test to Predict Successful Liberation From Renal Replacement Therapy in Critically Ill Patients”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: June 30, 2024

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.

Interventions

• 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.

Arms, Groups and Cohorts

• Critically ill patients undergoing RRT
  • Patients admitted to participating ICU and receiving renal replacement therapy.

Clinical Trial Outcome Measures

Primary Measures

• Successful liberation of RRT within 72 hours after FST
  • Time Frame: within 72 hours
  • No renal replacement therapy administered

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Centre Hospitalier Universitaire Vaudois
• Provider of Information About this Clinical Study
  • Principal Investigator: Antoine Schneider, Doctor – Centre Hospitalier Universitaire Vaudois
• Overall Official(s)
  • Antoine Schneider, MD PhD, Principal Investigator, Centre Hospitalier Universitaire Vaudois
• Overall Contact(s)
  • Antoine schneider, MD PhD, +41795561902, antoine.scheider@chuv.ch

Citations Reporting on Results

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.