Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

NCT02730117 | Completed DMC

• 1 other identifier: IRB.006/59
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Furosemide stress test; critical care

Outcome Measures

Primary Outcomes (1)

• Renal replacement therapy proportion

  Proportion of patients with FST responsiveness and nonresponsiveness who had received RRT

  28 days

Secondary Outcomes (10)

• 28-day mortality measured by number of deceased patients at 28-day after the enrollment

  28-day or until hospital discharge

• ICU-free days measured by number of days (28 days minus ICU length of stay)

  through study completion, an average of 28 days

• mechanical ventilator-free days measured by number of days (28 days minus days using mechanical ventilator)

  through study completion, an average of 28 days

• dialysis dependence measured by need for renal replacement therapy in 28 days

  through study completion, an average of 28 days

• 7-day fluid balance

  7 days

Study Arms (2)

Early renal replacement therapy

EXPERIMENTAL

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

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

Conventional renal replacement therapy

PLACEBO COMPARATOR

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

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

Interventions

Dialysis with continuous renal replacement therapy DEVICE

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

Conventional renal replacement therapy; Early renal replacement therapy

Mechanical ventilator DEVICE

Invasive or noninvasive form of respiratory support

Conventional renal replacement therapy; Early renal replacement therapy

Anti-Bacterial Agents DRUG

Antibacterial agents deemed appropriate by physicians in the ICU

Also known as: cephalosporin, carbapenem

Conventional renal replacement therapy; Early renal replacement therapy

Vasopressors DRUG

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Also known as: Norepinephrine, Dopamine, Milrinone, Dobutamine

Conventional renal replacement therapy; Early renal replacement therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Sasipha Tachaboon

Bangkok, Pathumwan, 10330, Thailand

Location

Related Publications (2)

• 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.

  PMID: 36416787 DERIVED

• 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.

  PMID: 29673370 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Dialysis; Continuous Renal Replacement Therapy; Ventilators, Mechanical; Anti-Bacterial Agents; Cephalosporins; Carbapenems; Vasoconstrictor Agents; Norepinephrine; Dopamine; Milrinone; Dobutamine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena; Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Equipment and Supplies; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cardiovascular Agents; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Amrinone; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Phenethylamines; Ethylamines

Study Officials

• Nattachai Srisawat, MD

  Excellence Center of Critical Care Nephrology, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Excellence Center for Critical Care Nephrology

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 6, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)