Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

NCT ID: NCT02730117

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-07-31

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

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Furosemide stress test; critical care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early 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

Group Type: EXPERIMENTAL

Dialysis with continuous renal replacement therapy

Intervention Type: DEVICE

Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU

Mechanical ventilator

Intervention Type: DEVICE

Invasive or noninvasive form of respiratory support

Anti-Bacterial Agents

Intervention Type: DRUG

Antibacterial agents deemed appropriate by physicians in the ICU

Vasopressors

Intervention Type: DRUG

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Conventional 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

Group Type: PLACEBO_COMPARATOR

Dialysis with continuous renal replacement therapy

Intervention Type: DEVICE

Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU

Mechanical ventilator

Intervention Type: DEVICE

Invasive or noninvasive form of respiratory support

Anti-Bacterial Agents

Intervention Type: DRUG

Antibacterial agents deemed appropriate by physicians in the ICU

Vasopressors

Intervention Type: DRUG

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Interventions

Dialysis with continuous renal replacement therapy

Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU

Intervention Type: DEVICE

Mechanical ventilator

Invasive or noninvasive form of respiratory support

Intervention Type: DEVICE

Anti-Bacterial Agents

Antibacterial agents deemed appropriate by physicians in the ICU

Intervention Type: DRUG

Vasopressors

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Intervention Type: DRUG

Other Intervention Names

cephalosporin; carbapenem; Norepinephrine; Dopamine; Milrinone; Dobutamine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Nattachai Srisawat ,M.D.

Director of Excellence Center for Critical Care Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nattachai Srisawat, MD

Role: PRINCIPAL_INVESTIGATOR

Excellence Center of Critical Care Nephrology, Chulalongkorn University

Locations

Sasipha Tachaboon

Bangkok, Pathumwan, Thailand

Countries

Thailand

References

Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

Reference Type: DERIVED

PMID: 36416787 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29673370 (View on PubMed)

Other Identifiers

IRB.006/59

Identifier Type: -

Identifier Source: org_study_id