Acute Kidney Injury
Conditions
Keywords
Acute kidney injury, Furosemide stress test, critical care
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
Interventions
Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU
DEVICEMechanical ventilator
Invasive or noninvasive form of respiratory support
DRUGAnti-Bacterial Agents
Antibacterial agents deemed appropriate by physicians in the ICU
DRUGVasopressors
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal replacement therapy proportion | 28 days | Proportion of patients with FST responsiveness and nonresponsiveness who had received RRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| RRT free days | through study completion, an average of 28 days | 28 days minus by days on RRT |
Countries
Thailand
Outcome results
None listed