Clinical trial

Protocol Based-furosemide Stress Test Versus Standard Care to Evaluate Renal Recovery During Continuous Renal Replacement Therapy: A Randomized Controlled Trial

Name

MED-2566-0034

Description

Currently, continuous renal replacement therapy (CRRT) is the main modality for renal support in critically ill patients with hemodynamic instability. Most studies have investigated the timing of RRT initiation. However, prolonged CRRT demonstrated the association of many unexpected events, such as catheter-related complications, catheter-related blood stream infection, hypotension, hypothermia, tachycardia, and atrial fibrillation. Up to now, there is a lack of evidence regarding the timing of withholding CRRT. The furosemide stress test (FST) is a tool that is easy to use and has more availability. The investigators aimed to apply FST to evaluate renal recovery compared with standard treatment in critically ill patients undergoing CRRT.

Trial arms

Trial start

2024-01-01

Estimated PCD

2024-06-07

Trial end

2024-06-07

Status

Recruiting

Phase

Early phase I

Treatment

Furosemide Injection

After taking furosemide at 1.5 mg/kg intravenously, if the urine output exceeds 200 mL within 2 hours, the patients are going to withhold CRRT. But if there is no response, the titration of furosemide to 2.5 mg/kg and 3.5 mg/kg every 6 hours is scheduled according to the urine output \>200 mL in 2 hours (not exceeding 250 mg).

Arms:

Protocol based-furosemide stress test

Other names:

Furosemide stress test

Size

Primary endpoint

% of patients with Renal recovery

5 days

Eligibility criteria

Inclusion Criteria: * Adult 20 year of age or older * Acute kidney injury (AKI) stage 3 according to Kidney Disease Improving Global Outcomes (KDIGO) classification with oliguria (urine \<400 ml/day) * Initiate CRRT in ICU (medical ICU, surgical ICU, cardiac care unit) for at least 48 hours (time for initiation and modality of CRRT can adjust by clinician) Exclusion Criteria: * Use any inotropic drug (norepinephrine, epinephrine, dopamine, dobutamine) * Blood urea nitrogen (BUN) \>80 mg/dL * Serum K \<3.5 or \>5 mmol/L * Arterial potential of Hydrogen (pH) \<7.3 * Serum bicarbonate (HCO3) \<15 mmol/L * Urine volume \<400 or \>2,100 mL/day * Urine creatinine clearance (CrCl) at 6 hours \>20 mL/min * Previous chronic kidney disease (CKD) stage 5 or estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2 * Previous RRT within 14 days * Kidney transplantation * Obstructive etiology for AKI * Toxin/drug that necessitates RRT * Allergy to furosemide * Moribund with expected death within 24 hours * Pregnancy

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-01-29

1 organization

1 product

1 indication

Organization

Chiang Mai University

Product

Furosemide

Indication

Acute Kidney Injury