Protocol Based-furosemide Stress Test Versus Standard Care to Evaluate Renal Recovery During Continuous Renal Replacement Therapy

Phase 4

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Drug: Furosemide Injection

• Registration Number: NCT06229990
• Lead Sponsor: Chiang Mai University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol based-furosemide stress test	Furosemide Injection	Furosemide at 1.5 mg/kg intravenously

Primary Outcome Measures

Name	Time	Method
% of patients with Renal recovery	5 days	Free of RRT for at least 5 days

Secondary Outcome Measures

Name	Time	Method
RRT free days	28 days	No need to restart RRT
% of patients with Mortality	28 days	28 days all cause mortality and in-hospital mortality
Ventilator-free day	28 days	Number of mechanical ventilator-free day
Day of Hospitalization	28 days	Length of hospital stay and ICU stay
% of complication	28 days	CRBSI, electrolyte imbalance, urine output
Cost of RRT during hospitalization	28 days	The cost of RRT since the initiation until the end of RRT during hospitalization in US dollar and Thai Baht unit

Trial Locations

Locations (1)

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand