Acute Kidney InjuryNCT02730117
Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy
A study testing Dialysis with continuous renal replacement therapy, Mechanical ventilator and Anti-Bacterial Agents in people with Acute Kidney Injury, run by Chulalongkorn University at 1 site in Thailand.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Dialysis with continuous renal replacement therapy, Mechanical ventilator and Anti-Bacterial Agents
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Acute Kidney Injury
- Being tested
- Dialysis with continuous renal replacement therapy, Mechanical ventilator, Anti-Bacterial Agents, Vasopressors
- Keywords
- Acute kidney injury, Furosemide stress test, critical care
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis with continuous renal replacement therapyDevice
Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU
Mechanical ventilatorDevice
Invasive or noninvasive form of respiratory support
Anti-Bacterial AgentsDrug
Also called cephalosporin, carbapenem
Antibacterial agents deemed appropriate by physicians in the ICU
VasopressorsDrug
Also called Norepinephrine, Dopamine, Milrinone, Dobutamine
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Dialysis with continuous renal replacement therapy; Device: Mechanical ventilator; Drug: Anti-Bacterial Agents; Drug: Vasopressors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal replacement therapy proportion
Proportion of patients with FST responsiveness and nonresponsiveness who had received RRT
Measured: 28 days
Secondary outcomes (10)
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
Measured: 28-day or until hospital discharge
ICU-free days measured by number of days (28 days minus ICU length of stay)
28 days minus by ICU length of stay
Measured: through study completion, an average of 28 days
mechanical ventilator-free days measured by number of days (28 days minus days using mechanical ventilator)
28 days minus by days using mechanical ventilator
Measured: through study completion, an average of 28 days
dialysis dependence measured by need for renal replacement therapy in 28 days
dialysis dependence at hospital discharge
Measured: through study completion, an average of 28 days
7-day fluid balance
7-day fluid balance
Measured: 7 days
RRT free days
28 days minus by days on RRT
Measured: through study completion, an average of 28 days
Length of ICU stay
Length of ICU stay
Measured: through study completion, an average of 28 days
Length of hospital stay
Length of hospital stay
Measured: through study completion, an average of 28 days
Renal recovery
Urine output > 1,000 ml without diuretics or > 2,000 ml with diuretics
Measured: through study completion, an average of 28 days
Adverse events
Adverse events
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
- Investigators
- Nattachai Srisawat, MD, Principal investigator, Excellence Center of Critical Care Nephrology, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730117
- Sponsor's protocol ID
- IRB.006/59
- Status last verified
- Dec 2017
- First submitted
- 18 Mar 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36416787Lumlertgul 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02730117
- Acronym / sponsor ID
- IRB.006/59
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Furosemide stress test, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early renal replacement therapy | Experimental | Device: Dialysis with continuous renal replacement therapy, Device: Mechanical ventilator, Drug: Anti-Bacterial Agents, Drug: VasopressorsDialysis 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 |
| Conventional renal replacement therapy | Placebo comparator | Device: Dialysis with continuous renal replacement therapy, Device: Mechanical ventilator, Drug: Anti-Bacterial Agents, Drug: VasopressorsDialysis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialysis with continuous renal replacement therapyContinuous renal replacement therapy is a form of 24-hour dialysis in the ICU | Device | Conventional renal replacement therapy, Early renal replacement therapy |
| Mechanical ventilatorInvasive or noninvasive form of respiratory support | Device | Conventional renal replacement therapy, Early renal replacement therapy |
| Anti-Bacterial AgentsAlso: cephalosporin, carbapenemAntibacterial agents deemed appropriate by physicians in the ICU | Drug | Conventional renal replacement therapy, Early renal replacement therapy |
| VasopressorsAlso: Norepinephrine, Dopamine, Milrinone, DobutamineVasopressors such as Norepinephrine, dopamine, milrinone, dobutamine | Drug | Conventional renal replacement therapy, Early renal replacement therapy |
Primary outcome
Renal replacement therapy proportion
Time frame: 28 days
Proportion of patients with FST responsiveness and nonresponsiveness who had received RRT
10 secondary outcomes
28-day mortality measured by number of deceased patients at 28-day after the enrollment
Time frame: 28-day or until hospital discharge
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
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
dialysis dependence measured by need for renal replacement therapy in 28 days
Time frame: through study completion, an average of 28 days
7-day fluid balance
Time frame: 7 days
RRT free days
Time frame: through study completion, an average of 28 days
Length of ICU stay
Time frame: through study completion, an average of 28 days
Length of hospital stay
Time frame: through study completion, an average of 28 days
Renal recovery
Time frame: through study completion, an average of 28 days
Adverse events
Time frame: through study completion, an average of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Derived from this study: PubMed 36416787Fayad 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.
- Derived from this study: PubMed 29673370Lumlertgul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nattachai Srisawat, MD principal investigator
Excellence Center of Critical Care Nephrology, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialysis with continuous renal replacement therapy, Mechanical ventilator and Anti-Bacterial Agents in people with Acute Kidney Injury, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal replacement therapy proportion (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730117, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.