Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy
Not Applicable
Completed
- Conditions
- Acute Kidney Injury
- Interventions
- Device: Dialysis with continuous renal replacement therapyDevice: Mechanical ventilatorDrug: Anti-Bacterial AgentsDrug: Vasopressors
- Registration Number
- NCT02730117
- Lead Sponsor
- Chulalongkorn University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early renal replacement therapy Anti-Bacterial Agents 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 Conventional renal replacement therapy Anti-Bacterial Agents 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 Conventional renal replacement therapy Mechanical ventilator 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 Early renal replacement therapy Dialysis with continuous renal replacement therapy 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 Early renal replacement therapy Mechanical ventilator 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 Conventional renal replacement therapy Vasopressors 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 Early renal replacement therapy Vasopressors 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 Conventional renal replacement therapy Dialysis with continuous renal replacement therapy 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
- Primary Outcome Measures
Name Time Method Renal replacement therapy proportion 28 days Proportion of patients with FST responsiveness and nonresponsiveness who had received RRT
- Secondary Outcome Measures
Name Time Method 28-day mortality measured by number of deceased patients at 28-day after the enrollment 28-day or until hospital discharge 28-day mortality measured by number of deceased patients at 28-day after the enrollment
ICU-free days measured by number of days (28 days minus ICU length of stay) through study completion, an average of 28 days 28 days minus by ICU length of stay
mechanical ventilator-free days measured by number of days (28 days minus days using mechanical ventilator) through study completion, an average of 28 days 28 days minus by days using mechanical ventilator
dialysis dependence measured by need for renal replacement therapy in 28 days through study completion, an average of 28 days dialysis dependence at hospital discharge
7-day fluid balance 7 days 7-day fluid balance
RRT free days through study completion, an average of 28 days 28 days minus by days on RRT
Length of ICU stay through study completion, an average of 28 days Length of ICU stay
Length of hospital stay through study completion, an average of 28 days Length of hospital stay
Renal recovery through study completion, an average of 28 days Urine output \> 1,000 ml without diuretics or \> 2,000 ml with diuretics
Adverse events through study completion, an average of 28 days Adverse events
Trial Locations
- Locations (1)
Sasipha Tachaboon
🇹🇭Bangkok, Pathumwan, Thailand