Back to results

Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

Primary Purpose

Acute Kidney Injury

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Dialysis with continuous renal replacement therapy

Mechanical ventilator

Anti-Bacterial Agents

Vasopressors

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute kidney injury, Furosemide stress test, critical care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sasipha Tachaboon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Early renal replacement therapy

Conventional renal replacement therapy

Arm Description

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

Dialysis with continuous renal replacement therapy machine e.g. Aquarius, Prismaflex, Infomed, after the patients reached at least one of the following criteria; pH < 7.15 or serum HCO3 < 15 mEq/L serum K >= 6 mEq/L Signs of volume overload or P/F ratio < 200 BUN > 60 mg/dL Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate

Outcomes

Primary Outcome Measures

Renal replacement therapy proportion

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

Secondary Outcome Measures

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

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

28 days minus by ICU length of stay

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

28 days minus by days using mechanical ventilator

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

dialysis dependence at hospital discharge

7-day fluid balance

RRT free days

28 days minus by days on RRT

Length of ICU stay

Length of hospital stay

Renal recovery

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

Adverse events

Full Information

NCT ID

NCT02730117

First Posted

March 18, 2016

Last Updated

December 17, 2017

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT02730117

Brief Title

Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

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 Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

Acute kidney injury, Furosemide stress test, critical care

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early renal replacement therapy

Arm Type

Experimental

Arm Description

Arm Title

Conventional renal replacement therapy

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Dialysis with continuous renal replacement therapy

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Mechanical ventilator

Intervention Description

Invasive or noninvasive form of respiratory support

Intervention Type

Drug

Intervention Name(s)

Anti-Bacterial Agents

Other Intervention Name(s)

cephalosporin, carbapenem

Intervention Description

Antibacterial agents deemed appropriate by physicians in the ICU

Intervention Type

Drug

Intervention Name(s)

Vasopressors

Other Intervention Name(s)

Norepinephrine, Dopamine, Milrinone, Dobutamine

Intervention Description

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Primary Outcome Measure Information:

Title

Renal replacement therapy proportion

Description

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

28-day or until hospital discharge

Title

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

Description

28 days minus by ICU length of stay

Time Frame

through study completion, an average of 28 days

Title

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

Description

28 days minus by days using mechanical ventilator

Time Frame

through study completion, an average of 28 days

Title

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

Description

dialysis dependence at hospital discharge

Time Frame

through study completion, an average of 28 days

Title

7-day fluid balance

Description

7-day fluid balance

Time Frame

7 days

Title

RRT free days

Description

28 days minus by days on RRT

Time Frame

through study completion, an average of 28 days

Title

Length of ICU stay

Description

Length of ICU stay

Time Frame

through study completion, an average of 28 days

Title

Length of hospital stay

Description

Length of hospital stay

Time Frame

through study completion, an average of 28 days

Title

Renal recovery

Description

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

Time Frame

through study completion, an average of 28 days

Title

Adverse events

Description

Adverse events

Time Frame

through study completion, an average of 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nattachai Srisawat, MD

Organizational Affiliation

Excellence Center of Critical Care Nephrology, Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sasipha Tachaboon

City

Bangkok

State/Province

Pathumwan

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29673370

Citation

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.

Results Reference

derived

Learn more about this trial

Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy

We'll reach out to this number within 24 hrs