Acute Kidney InjuryPhase 4FURTHERNCT03731117
FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
A Phase 4 study testing Furosemide in people with Acute Kidney Injury, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. 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?
- Furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Jul 2019to 7 Dec 2020
- Phase
- Phase 4
- 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 over 18 years old
- Hospitalized in ICU at day of inclusion
- Diagnosis of sepsis defined as proven or suspected infection and increase of the SOFA (Sequential Organ Failure Assessment) score by 2 points or more compared to basal OR Cardiothoracic surgery with CBP (Cardiopulmonary bypass) within 72 hours before inclusion
- Adequate cardiac output and volemia assessed by cardiac ultrasound, venous saturation in Oxygen (ScVO2) or ΔPP
- Hemodynamic stabilization : stable norepinephrine dosage (or <20% variations) with no vascular filling during the last 3 hours
- AKI stage I or II in KDIGO classification
Who cannot join
- Chronic Kidney Disease with glomerular filtration rate ≤ 30 ml/mn/1,73m2
- Obstructive AKI
- AKI stage III in KDIGO classification
- Known allergy to loop diuretics
- Contraindications to Furosemide
- FST not feasible within 12 hours of eligibility
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- Previous AKI during the same hospitalization
- Pregnancy or breastfeeding women
- Subject under a legal protective measure
- No affiliation to a social regime or CMU
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Cote Basque
Bayonne
Hopital Saint Louis
Paris, 75010
Hopital Bichat
Paris, 75018
About this study
Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.
Read the detailed description
FURTHER will enroll consecutive patients with AKI KDIGO stage 1 or 2 associated with a sepsis or following a cardiac surgery with CPB within 72h. Patients must have achieved a hemodynamic stabilization confirmed by clinical (no need for intravenous fluids, no significant variation of noradrenaline) and non-clinical (trans-thoracic echocardiography, passive leg rise or other validated tool) assessment. Included patients will receive 1 to 1.5 mg/kg of FUROSEMIDE. Urine output will be measured for 6 hours and compensated by the same volume of intravenous crystalloids. Need for RRT will be assess at 2-hour, 6-hour and daily up to day 7, following the AKIKI-study delayed initiation arm criteria. FURTHER aim to evaluate FST in a well-defined prospective cohort of ischemic ATN-related AKI as predictor of need for RRT within a week.
- Conditions
- Acute Kidney Injury
- Being tested
- Furosemide
- Keywords
- Ischemic Acute Kidney Injury, Intensive care units, AKI, ICU, FST, FUROSEMIDE STRESS TEST, RRT, Renal Replacement Therapy, sepsis, Cardio-pulmonary bypass
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called furosemide stress test
Furosemide (FUROSEMIDE®) 20 mg / 2ml, ampoule for injection
1 mg / kg slow intravenous injection 1.5 mg / kg if chronic exposure to diuretics in the week prior to inclusion Measurement of urine output after two and six hours. Compensation of diuresis by same volume of crystalloids over a 6-hour period
| Study group | Role | What they receive |
|---|---|---|
| FST | Experimental | FUROSEMIDE STRESS TEST Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for renal replacement therapy or death
Need for renal replacement therapy will be define according to the AKIKI study (Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, et al. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33). Need for RRT following AKIKI delayed initiation criteria.
FST performance will be compared to the need of RRT or death.
Measured: Before day 7
sensitivity
FST will be positive if patient is non responder : 2-hour urine output < 200mL
Measured: 3 hour after FST
Secondary outcomes (5)
6 hour urine output
measurement of urine out
Measured: 6 hour after FST
percentage of effective renal replacement therapy
Initiation of RRT
Measured: daily up to day 7
death
Measured: daily up to day 7
hemodynamic safety: noradrenaline dose
noradrenaline dose
Measured: 6 hour after FST
clinical safety: arterial pressure
modification of systolic, diastolic or mean arterial blood pressure
Measured: 6 hour after FST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start15 Jul 2019
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Why it stopped: Study end date exceeded and insufficient number of subjects needed for analysis. 11 patients included / 70 theoretical patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-comparative, multicenter, study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731117
- Sponsor's protocol ID
- P170404J
- Acronym
- FURTHER
- Status last verified
- Dec 2020
- First submitted
- 10 Oct 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
- ClinicalTrials.gov ID
- NCT03731117
- Acronym / sponsor ID
- FURTHER / P170404J
- Conditions
- Acute Kidney Injury
- Keywords
- Ischemic Acute Kidney Injury, Intensive care units, AKI, ICU, FST, FUROSEMIDE STRESS TEST, RRT, Renal Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study end date exceeded and insufficient number of subjects needed for analysis. 11 patients included / 70 theoretical patients
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 6 Nov 2018 (actual)
- 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.
Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.
Detailed description
FURTHER will enroll consecutive patients with AKI KDIGO stage 1 or 2 associated with a sepsis or following a cardiac surgery with CPB within 72h. Patients must have achieved a hemodynamic stabilization confirmed by clinical (no need for intravenous fluids, no significant variation of noradrenaline) and non-clinical (trans-thoracic echocardiography, passive leg rise or other validated tool) assessment. Included patients will receive 1 to 1.5 mg/kg of FUROSEMIDE. Urine output will be measured for 6 hours and compensated by the same volume of intravenous crystalloids. Need for RRT will be assess at 2-hour, 6-hour and daily up to day 7, following the AKIKI-study delayed initiation arm criteria. FURTHER aim to evaluate FST in a well-defined prospective cohort of ischemic ATN-related AKI as predictor of need for RRT within a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-comparative, multicenter, study
| Arm | Type | Receives |
|---|---|---|
| FST | Experimental | Drug: FurosemideFUROSEMIDE STRESS TEST |
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 over 18 years old
- Hospitalized in ICU at day of inclusion
- Diagnosis of sepsis defined as proven or suspected infection and increase of the SOFA (Sequential Organ Failure Assessment) score by 2 points or more compared to basal OR Cardiothoracic surgery with CBP (Cardiopulmonary bypass) within 72 hours before inclusion
- Adequate cardiac output and volemia assessed by cardiac ultrasound, venous saturation in Oxygen (ScVO2) or ΔPP
- Hemodynamic stabilization : stable norepinephrine dosage (or <20% variations) with no vascular filling during the last 3 hours
Key exclusion criteria (10 listed)
- Chronic Kidney Disease with glomerular filtration rate ≤ 30 ml/mn/1,73m2
- Obstructive AKI
- AKI stage III in KDIGO classification
- Known allergy to loop diuretics
- Contraindications to Furosemide
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 |
|---|---|---|
| FurosemideAlso: furosemide stress testFurosemide (FUROSEMIDE®) 20 mg / 2ml, ampoule for injection 1 mg / kg slow intravenous injection 1.5 mg / kg if chronic exposure to diuretics in the week prior to inclusion Measurement of urine output after two and six hours. Compensation of diuresis by same volume of crystalloids over a 6-hour period | Drug | FST |
Primary outcome
Need for renal replacement therapy or death
Time frame: Before day 7
Need for renal replacement therapy will be define according to the AKIKI study (Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, et al. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33). Need for RRT following AKIKI delayed initiation criteria. FST performance will be compared to the need of RRT or death.
sensitivity
Time frame: 3 hour after FST
FST will be positive if patient is non responder : 2-hour urine output < 200mL
5 secondary outcomes
6 hour urine output
Time frame: 6 hour after FST
percentage of effective renal replacement therapy
Time frame: daily up to day 7
death
Time frame: daily up to day 7
hemodynamic safety: noradrenaline dose
Time frame: 6 hour after FST
clinical safety: arterial pressure
Time frame: 6 hour after FST
Results and safety
The study was stopped early (reason given: Study end date exceeded and insufficient number of subjects needed for analysis. 11 patients included / 70 theoretical patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide in people with Acute Kidney Injury, run by Assistance Publique - Hôpitaux de Paris at 3 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 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: stopped early, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study end date exceeded and insufficient number of subjects needed for analysis. 11 patients included / 70 theoretical patients). 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?
Need for renal replacement therapy or death (time frame: Before day 7). The study lists 2 primary outcomes in all. 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 16 Dec 2020.