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

Acute Kidney Injury Clinical Trial

— PAUSE-CRRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229990
• Other study ID #: MED-2566-0034
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Est. completion date: June 7, 2024

Study information

• Verified date: January 2024
• Source: Chiang Mai University
• Contact: Prit Kusirisin, MD
• Phone: +66897574028
• Email: jingprit[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Thailand	Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

Akhoundi A, Singh B, Vela M, Chaudhary S, Monaghan M, Wilson GA, Dillon JJ, Cartin-Ceba R, Lieske JC, Gajic O, Kashani K. Incidence of Adverse Events during Continuous Renal Replacement Therapy. Blood Purif. 2015;39(4):333-9. doi: 10.1159/000380903. Epub — View Citation

Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Bl — View 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): — View Citation

Gaudry S, Hajage D, Martin-Lefevre L, Lebbah S, Louis G, Moschietto S, Titeca-Beauport D, Combe B, Pons B, de Prost N, Besset S, Combes A, Robine A, Beuzelin M, Badie J, Chevrel G, Bohe J, Coupez E, Chudeau N, Barbar S, Vinsonneau C, Forel JM, Thevenin D, — View Citation

Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, Boyer A, Chevrel G, Lerolle N, Carpentier D, de Prost N, Lautrette A, Bretagnol A, Mayaux J, Nseir S, Megarbane B, Thirion M, Forel JM, Maizel J, Yonis H, Markowicz P, Thiery G, Tubach F — View Citation

Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x. — View Citation

Lumlertgul N, Peerapornratana S, Trakarnvanich T, Pongsittisak W, Surasit K, Chuasuwan A, Tankee P, Tiranathanagul K, Praditpornsilpa K, Tungsanga K, Eiam-Ong S, Kellum JA, Srisawat N; FST Study Group. Early versus standard initiation of renal replacement — View Citation

Park S, Lee S, Jo HA, Han K, Kim Y, An JN, Joo KW, Lim CS, Kim YS, Kim H, Kim DK. Epidemiology of continuous renal replacement therapy in Korea: Results from the National Health Insurance Service claims database from 2005 to 2016. Kidney Res Clin Pract. 2 — View Citation

STARRT-AKI Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group; United Kingdom Critical Care Research Group; Canadian Nephrology Trials Network; Irish Critical Care Trials Group; Bags — View Citation

Zarbock A, Kellum JA, Schmidt C, Van Aken H, Wempe C, Pavenstadt H, Boanta A, Gerss J, Meersch M. Effect of Early vs Delayed Initiation of Renal Replacement Therapy on Mortality in Critically Ill Patients With Acute Kidney Injury: The ELAIN Randomized Cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with Renal recovery	Free of RRT for at least 5 days	5 days
Secondary	% of patients with Mortality	28 days all cause mortality and in-hospital mortality	28 days
Secondary	RRT free days	No need to restart RRT	28 days
Secondary	Day of Hospitalization	Length of hospital stay and ICU stay	28 days
Secondary	Ventilator-free day	Number of mechanical ventilator-free day	28 days
Secondary	% of complication	CRBSI, electrolyte imbalance, urine output	28 days
Secondary	Cost of RRT during hospitalization	The cost of RRT since the initiation until the end of RRT during hospitalization in US dollar and Thai Baht unit	28 days