Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

Chulalongkorn University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Device: Mechanical ventilator; Drug: Vasopressors; Device: Dialysis with continuous renal replacement therapy; Drug: Anti-Bacterial Agents

Study type: Interventional

Funder types: Other

Identifiers

NCT02730117

IRB.006/59

Details and patient eligibility

About

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

Full 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

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups, including a placebo group

Early renal replacement therapy

Experimental group

Description:

Dialysis with continuous renal replacement therapy machine e.g. Aquarius, Prismaflex, Infomed, starting within 12 hours after randomization Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate

Treatment:

Device: Dialysis with continuous renal replacement therapy

Drug: Anti-Bacterial Agents

Device: Mechanical ventilator

Drug: Vasopressors

Conventional renal replacement therapy

Placebo Comparator group

Description:

Dialysis with continuous renal replacement therapy machine e.g. Aquarius, Prismaflex, Infomed, after the patients reached at least one of the following criteria; 1. pH \< 7.15 or serum HCO3 \< 15 mEq/L 2. serum K \>= 6 mEq/L 3. Signs of volume overload or P/F ratio \< 200 4. BUN \> 60 mg/dL Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate

Treatment:

Device: Dialysis with continuous renal replacement therapy

Drug: Anti-Bacterial Agents

Device: Mechanical ventilator

Drug: Vasopressors