Critical IllnessNCT02800135
Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients Recovery in the Short Term
A study testing Furosemide in people with Critical Illness and Oliguria, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
Acute kidney injury (AKI) is a common disorder and associated with high morbidity and mortality. However, distinguishing transient AKI from persistent AKI may help in individualizing treatment and limit short and long term consequences of AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Oliguria
- What is being tested?
- Furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 4 sitesFrance
- Study dates
- 11 Apr 2016to 21 Mar 2018
- 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
- Adult patients (age > 18 y.o)
- AKI stage 1 or more according to KDIGO
- Oliguria as defined by an oliguria lower than 0.5 mL/Kg
- Affiliation to the National Medical Insurance
Who cannot join
- Pregnancy
- Chronic kidney disease stage 4 or more
- Need for fluid bolus (>1000 mL crystalloids or equivalent) or need for vasopressors increases or introduction in the 2 hours preceding inclusion
- Evidence of obstructive renal failure
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de CLERMONT-FERRAND
Clermont-Ferrand, 63000
CHU de MONTPELLIER
Montpellier, 34000
CHU de SAINT-ETIENNE
Saint-Etienne, 42000
CHRU de STRASBOURG
Strasbourg, 67000
About this study
Official title: Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients
Acute kidney injury (AKI) is a common disorder and associated with high morbidity and mortality. However, distinguishing transient AKI from persistent AKI may help in individualizing treatment and limit short and long term consequences of AKI. Previous studies suggested usual urinary indices to perform poorly for separating transient from persistent AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease Improving Global Outcomes) guidelines underlined the need for additional strategies in estimating renal short term prognosis.
Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically ill patients. This stress test performance was found to be good in predicting capacity to identify those patients that will progress to advanced stage AKI. Additionally, FST performance was higher than those of usual renal biomarker. The limited sample size of this preliminary study however precluded adjustment for usual confounders including oliguria.
The primary objective of this study is to assess diagnostic performance of FST in differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic performance of FST in predicting need for renal replacement therapy, and to confirm FST results after adjustment for confounders.
- Conditions
- Critical Illness, Oliguria
- Being tested
- Furosemide
- Medical subject headings
- Critical Illness, Oliguria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
1.0 mg/kg of intravenous furosemide. In order to minimize the risk of hypovolemia, urine output will be replaced ml for ml with either Ringers lactate or normal saline for six hours after the furosemide stress test.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide stress test | Experimental | Not described Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with renal recovery
Measured: day 3
Secondary outcomes (5)
natriuresis(mmol/L)
Measured: day 0 to day 3
fractional excretion of sodium(%)
Measured: day 0 to day 3
fractional excretion of urea (%),
Measured: day 0 to day 3
U/P urea ratio(mg.dl-1/ mg.dl-1)
Measured: day 0 to day 3
U/P creatinine ratio (mg.dl-1/ mg.dl-1)
Measured: day 0 to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start11 Apr 2016
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Why it stopped: departure of the coordinating investigator from another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael DARMON, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800135
- Sponsor's protocol ID
- 1408024
- Other IDs
- 141521A-11, 2014-005146-22, 2014
- Status last verified
- Jun 2019
- First submitted
- 18 Dec 2015
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients
- ClinicalTrials.gov ID
- NCT02800135
- Acronym / sponsor ID
- 1408024
- Conditions
- Critical Illness, Oliguria
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of the coordinating investigator from another institution
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 15 Jun 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.
Acute kidney injury (AKI) is a common disorder and associated with high morbidity and mortality. However, distinguishing transient AKI from persistent AKI may help in individualizing treatment and limit short and long term consequences of AKI. Previous studies suggested usual urinary indices to perform poorly for separating transient from persistent AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease Improving Global Outcomes) guidelines underlined the need for additional strategies in estimating renal short term prognosis.
Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically ill patients. This stress test performance was found to be good in predicting capacity to identify those patients that will progress to advanced stage AKI. Additionally, FST performance was higher than those of usual renal biomarker. The limited sample size of this preliminary study however precluded adjustment for usual confounders including oliguria.
The primary objective of this study is to assess diagnostic performance of FST in differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic performance of FST in predicting need for renal replacement therapy, and to confirm FST results after adjustment for confounders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furosemide stress test | Experimental | Drug: Furosemide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age > 18 y.o)
- AKI stage 1 or more according to KDIGO
- Oliguria as defined by an oliguria lower than 0.5 mL/Kg
- Affiliation to the National Medical Insurance
Key exclusion criteria (4 listed)
- Pregnancy
- Chronic kidney disease stage 4 or more
- Need for fluid bolus (>1000 mL crystalloids or equivalent) or need for vasopressors increases or introduction in the 2 hours preceding inclusion
- Evidence of obstructive renal failure
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 |
|---|---|---|
| Furosemide1.0 mg/kg of intravenous furosemide. In order to minimize the risk of hypovolemia, urine output will be replaced ml for ml with either Ringers lactate or normal saline for six hours after the furosemide stress test. | Drug | Furosemide stress test |
Primary outcome
Number of patients with renal recovery
Time frame: day 3
5 secondary outcomes
natriuresis(mmol/L)
Time frame: day 0 to day 3
fractional excretion of sodium(%)
Time frame: day 0 to day 3
fractional excretion of urea (%),
Time frame: day 0 to day 3
U/P urea ratio(mg.dl-1/ mg.dl-1)
Time frame: day 0 to day 3
U/P creatinine ratio (mg.dl-1/ mg.dl-1)
Time frame: day 0 to day 3
Results and safety
The study was stopped early (reason given: departure of the coordinating investigator from another institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- 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.
Michael DARMON, MD PhD principal investigator
CHU de SAINT-ETIENNE
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide in people with Critical Illness and Oliguria, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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. 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 was stopped early (reason given: departure of the coordinating investigator from another institution). Results are not available in the source record.
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?
Number of patients with renal recovery (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2019.