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CompletedNCT02730117Updated Dec 19, 2017

Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

An interventional study of Dialysis with continuous renal replacement therapy and Mechanical ventilator in Acute Kidney Injury, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-19.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

Read the 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

02

Conditions studied

  • Acute Kidney Injury

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Keywords

  • Acute kidney injury
  • Furosemide stress test
  • critical care
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 118 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • 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 · Device: Mechanical ventilator · Drug: Anti-Bacterial Agents · Drug: Vasopressors

  • 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 · Device: Mechanical ventilator · Drug: Anti-Bacterial Agents · Drug: Vasopressors

Interventions

  • DeviceDialysis with continuous renal replacement therapy

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

  • DeviceMechanical ventilator

    Invasive or noninvasive form of respiratory support

  • DrugAnti-Bacterial Agents

    Antibacterial agents deemed appropriate by physicians in the ICU

    Also known as: cephalosporin, carbapenem

  • DrugVasopressors

    Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

    Also known as: Norepinephrine, Dopamine, Milrinone, Dobutamine

06

What researchers measure

Primary outcomes

  1. Renal replacement therapy proportion

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

    Time frame: 28 days

Secondary outcomes

  1. 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

    Time frame: 28-day or until hospital discharge

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

    28 days minus by ICU length of stay

    Time frame: through study completion, an average of 28 days

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

    28 days minus by days using mechanical ventilator

    Time frame: through study completion, an average of 28 days

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

    dialysis dependence at hospital discharge

    Time frame: through study completion, an average of 28 days

  5. 7-day fluid balance

    7-day fluid balance

    Time frame: 7 days

  6. RRT free days

    28 days minus by days on RRT

    Time frame: through study completion, an average of 28 days

  7. Length of ICU stay

    Length of ICU stay

    Time frame: through study completion, an average of 28 days

  8. Length of hospital stay

    Length of hospital stay

    Time frame: through study completion, an average of 28 days

  9. Renal recovery

    Urine output \> 1,000 ml without diuretics or \> 2,000 ml with diuretics

    Time frame: through study completion, an average of 28 days

  10. Adverse events

    Adverse events

    Time frame: through study completion, an average of 28 days

07

Study locations

1 site
  • Sasipha Tachaboon
    Bangkok, Pathumwan 10330, Thailand
08

References and documents

Publications

  • 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. PubMed 29673370 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02730117
Lead sponsor
Chulalongkorn University
Responsible party
Nattachai Srisawat ,M.D. (Director of Excellence Center for Critical Care Nephrology, Chulalongkorn University) — Principal investigator
First posted
Apr 6, 2016
Start date
Mar 2016
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Dec 19, 2017

Study contacts

Nattachai Srisawat, MD
principal investigator · Excellence Center of Critical Care Nephrology, Chulalongkorn University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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