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Completed

NCT Number: NCT02730117

Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sasipha Tachaboon

Bangkok, Pathumwan, 10330, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysis with continuous renal replacement therapy

Device

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

Mechanical ventilator

Device

Invasive or noninvasive form of respiratory support

Anti-Bacterial Agents

Drug

Antibacterial agents deemed appropriate by physicians in the ICU

Other names: cephalosporin, carbapenem

Vasopressors

Drug

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Other names: Norepinephrine, Dopamine, Milrinone, Dobutamine

Primary outcomes

  1. Renal replacement therapy proportion

    Time frame: 28 days

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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