Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730117
• Other study ID #: IRB.006/59
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: December 17, 2017
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Device:
• Dialysis with continuous renal replacement therapy
Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU
• Mechanical ventilator
Invasive or noninvasive form of respiratory support

Drug:
• Anti-Bacterial Agents
Antibacterial agents deemed appropriate by physicians in the ICU
• Vasopressors
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Locations

Country	Name	City	State
Thailand	Sasipha Tachaboon	Bangkok	Pathumwan

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal replacement therapy proportion	Proportion of patients with FST responsiveness and nonresponsiveness who had received RRT	28 days
Secondary	28-day mortality measured by number of deceased patients at 28-day after the enrollment	28-day mortality measured by number of deceased patients at 28-day after the enrollment	28-day or until hospital discharge
Secondary	ICU-free days measured by number of days (28 days minus ICU length of stay)	28 days minus by ICU length of stay	through study completion, an average of 28 days
Secondary	mechanical ventilator-free days measured by number of days (28 days minus days using mechanical ventilator)	28 days minus by days using mechanical ventilator	through study completion, an average of 28 days
Secondary	dialysis dependence measured by need for renal replacement therapy in 28 days	dialysis dependence at hospital discharge	through study completion, an average of 28 days
Secondary	7-day fluid balance	7-day fluid balance	7 days
Secondary	RRT free days	28 days minus by days on RRT	through study completion, an average of 28 days
Secondary	Length of ICU stay	Length of ICU stay	through study completion, an average of 28 days
Secondary	Length of hospital stay	Length of hospital stay	through study completion, an average of 28 days
Secondary	Renal recovery	Urine output > 1,000 ml without diuretics or > 2,000 ml with diuretics	through study completion, an average of 28 days
Secondary	Adverse events	Adverse events	through study completion, an average of 28 days