Clinical trial NCT02730117: Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy
Official title: Does Early Initiation of Renal Replacement Therapy Have an Impact on 7-day Fluid Balance in Critically Ill Patients With Acute Kidney Injury With Positive Furosemide Stress Test?: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Furosemide stress test
critical care
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Does Early Initiation of Renal Replacement Therapy Have an Impact on 7-day Fluid Balance in Critically Ill Patients with Acute Kidney Injury with Positive Furosemide Stress Test?: a Multicenter Randomized Controlled Trial

Detailed description: The objective is to determine if early initiation of renal replacement therapy guided by positive furosemide stress test has an impact on 7-day fluid balance in critically ill patients with acute kidney injury

Eligibility criteria: Inclusion Criteria:

* Age older than 18 years old and admission in an ICU
* Acute kidney injury (defined by serum creatinine increase ≥ 0.3 mg/dL or urine output ≤ 0.5 mL/kg/hour according to KDIGO criteria)
* Informed consent provided by the patient or person with decisional responsibility
* Indwelling bladder catheter
* Documented cause of acute kidney injury from acute tubular necrosis e.g. presence of granular or epithelial casts on urine sediment, FeNa more than 1%, Feurea more than 50%, urine or plasma neutrophil gelatinase-associated lipocalin (NGAL) more than 150 mg/dL
* Opinion of the treating clinical team that patient was well resuscitated and sufficiently clinically stable for the intervention or by noninvasive or invasive measurements i.e. fluid accumulation at least 5% plus at least one of the following e.g. chest radiography, central venous pressure ≥ 8 mmHg, pulse pressure variation \< 13%, inferior vena cava collapsibility index \< 50% in spontaneously breathing patients or distensibility index \< 18% in mechanically ventilated patients

Exclusion Criteria:

* Baseline serum creatinine ≥ 2 mg/dL (male) and ≥ 1.5 mg/dL (female) within 3 months
* Evidence of volume depletion at the time of furosemide administration or active bleeding
* Evidence of obstructive uropathy, renal vein thrombosis or renal artery stenosis, thrombotic microangiopathy, glomerulonephritis, tumor lysis syndrome
* History of renal allograft
* Known pregnancy
* Allergy or known sensitivity to loop diuretics
* Need for emergency renal replacement therapy at randomization or evaluation by the clinical team that the renal replacement therapy should be deferred
* Patient is moribund with expected death within 24 hr or whom survival to 28 days is unlikely due to an uncontrollable comorbidity (cardiac, pulmonary or hepatic end-stage disease; hepatorenal syndrome; poorly controlled cancer; severe post-anoxic encephalopathy; etc.)
* Patients with advance directives issued expressing the desire not to be resuscitated
* Prior treatment with RRT within 30 days

Primary outcomes:
measure: Renal replacement therapy proportion
timeFrame: 28 days
Secondary outcomes:
measure: 28-day mortality measured by number of deceased patients at 28-day after the enrollment
timeFrame: 28-day or until hospital discharge
measure: ICU-free days measured by number of days (28 days minus ICU length of stay)
timeFrame: through study completion, an average of 28 days
measure: mechanical ventilator-free days measured by number of days (28 days minus days using mechanical ventilator)
timeFrame: through study completion, an average of 28 days
measure: dialysis dependence measured by need for renal replacement therapy in 28 days
timeFrame: through study completion, an average of 28 days
measure: 7-day fluid balance
timeFrame: 7 days
measure: RRT free days
timeFrame: through study completion, an average of 28 days
measure: Length of ICU stay
timeFrame: through study completion, an average of 28 days
measure: Length of hospital stay
timeFrame: through study completion, an average of 28 days
measure: Renal recovery
timeFrame: through study completion, an average of 28 days
measure: Adverse events
timeFrame: through study completion, an average of 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sasipha Tachaboon
state: Pathumwan
Study officials:
affiliation: Excellence Center of Critical Care Nephrology, Chulalongkorn University
name: Nattachai Srisawat, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 therapy in furosemide stress test non-responsive acute kidney injury patients (the FST trial). Crit Care. 2018 Apr 19;22(1):101. doi: 10.1186/s13054-018-2021-1.