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Recruiting NCT06229990

Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury

Phase IV Interventional Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Furosemide Injection.
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury (FST-LIBERATE)

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • % of patients with Renal recovery [Time frame: 5 days]
Secondary outcome measures (6)
  • % of patients with Mortality [Time frame: 28 days]
  • RRT free days [Time frame: 28 days]
  • Day of Hospitalization [Time frame: 28 days]
  • Ventilator-free day [Time frame: 28 days]
  • % of complication [Time frame: 28 days]
  • Cost of RRT during hospitalization [Time frame: 28 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Chiang Mai University — Chiang Mai

Publications

  • 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. 2018 Jun;37(2):119-129. doi: 10.23876/j.krcp.2018.37.2.119. Epub 2018 Jun 30. PMID 29971207
  • 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, Ricard JD, Dreyfuss D; AKIKI Study Group. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Ju PMID 27181456
  • 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 Clinical Trial. JAMA. 2016 May 24-31;315(20):2190-9. doi: 10.1001/jama.2016.5828. PMID 27209269
  • 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, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL- PMID 30304656
  • 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; Bagshaw SM, Wald R, Adhikari NKJ, Bellomo R, da Costa BR, Dreyfuss D, Du B, Gallagher MP, Gaudry S, Hoste EA, Lamontagne F, Joannidis M, Landoni G, L PMID 32668114
  • 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, Boulet E, Lakhal K, Aissaoui N, Grange S, Leone M, Lacave G, Nseir S, Poirson F, Mayaux J, Asehnoune K, Geri G, Klouche K, Thiery G, Argaud L, R PMID 33812488
  • 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 2015 May 22. PMID 26022612
  • 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. PMID 24053972

Identifiers

NCT: NCT06229990 · MED-2566-0034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗