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Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

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ClinicalTrials.gov Identifier: NCT02730117
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Nattachai Srisawat ,M.D., 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

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Device: Dialysis with continuous renal replacement therapy Device: Mechanical ventilator Drug: Anti-Bacterial Agents Drug: Vasopressors Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: 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

Device: Dialysis with continuous renal replacement therapy
Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU

Device: Mechanical ventilator
Invasive or noninvasive form of respiratory support

Drug: Anti-Bacterial Agents
Antibacterial agents deemed appropriate by physicians in the ICU
Other Names:
  • cephalosporin
  • carbapenem

Drug: Vasopressors
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
Other Names:
  • Norepinephrine
  • Dopamine
  • Milrinone
  • Dobutamine

Placebo Comparator: 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

Device: Dialysis with continuous renal replacement therapy
Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU

Device: Mechanical ventilator
Invasive or noninvasive form of respiratory support

Drug: Anti-Bacterial Agents
Antibacterial agents deemed appropriate by physicians in the ICU
Other Names:
  • cephalosporin
  • carbapenem

Drug: Vasopressors
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
Other Names:
  • Norepinephrine
  • Dopamine
  • Milrinone
  • Dobutamine




Primary Outcome Measures :
  1. Renal replacement therapy proportion [ Time Frame: 28 days ]
    Proportion of patients with FST responsiveness and nonresponsiveness who had received RRT


Secondary Outcome Measures :
  1. 28-day mortality measured by number of deceased patients at 28-day after the enrollment [ Time Frame: 28-day or until hospital discharge ]
    28-day mortality measured by number of deceased patients at 28-day after the enrollment

  2. ICU-free days measured by number of days (28 days minus ICU length of stay) [ Time Frame: through study completion, an average of 28 days ]
    28 days minus by ICU length of stay

  3. mechanical ventilator-free days measured by number of days (28 days minus days using mechanical ventilator) [ Time Frame: through study completion, an average of 28 days ]
    28 days minus by days using mechanical ventilator

  4. dialysis dependence measured by need for renal replacement therapy in 28 days [ Time Frame: through study completion, an average of 28 days ]
    dialysis dependence at hospital discharge

  5. 7-day fluid balance [ Time Frame: 7 days ]
    7-day fluid balance

  6. RRT free days [ Time Frame: through study completion, an average of 28 days ]
    28 days minus by days on RRT

  7. Length of ICU stay [ Time Frame: through study completion, an average of 28 days ]
    Length of ICU stay

  8. Length of hospital stay [ Time Frame: through study completion, an average of 28 days ]
    Length of hospital stay

  9. Renal recovery [ Time Frame: through study completion, an average of 28 days ]
    Urine output > 1,000 ml without diuretics or > 2,000 ml with diuretics

  10. Adverse events [ Time Frame: through study completion, an average of 28 days ]
    Adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730117


Locations
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Thailand
Sasipha Tachaboon
Bangkok, Pathumwan, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Nattachai Srisawat, MD Excellence Center of Critical Care Nephrology, Chulalongkorn University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nattachai Srisawat ,M.D., Director of Excellence Center for Critical Care Nephrology, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02730117     History of Changes
Other Study ID Numbers: IRB.006/59
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nattachai Srisawat ,M.D., Chulalongkorn University:
Acute kidney injury
Furosemide stress test
critical care
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Dopamine
Dobutamine
Milrinone
Furosemide
Norepinephrine
Vasoconstrictor Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Protective Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Platelet Aggregation Inhibitors