Renal CongestionECHOFURONCT03704844
Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU
An observational study of Renal Congestion, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial summary
Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect. The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Congestion
- What is being tested?
- non applicable
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2018to Dec 2021
- Phase
- Observational
- 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
Study population: ICU patients under treatment by furosemide
Who may be able to join
- patient hospitalized in ICU
- under furosemide treatment
Who cannot join
- participation refusal
- uncontrolled shock (MAP<65mmHg)
- abdominal compartment syndrome
- diuretic administration in the 6 hours prior to inclusion
- renal replacement therapy or stage 4-5 chronic kidney disease
- atrial fibrillation
- no monitoring of CVP / invasive arterial pressure
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
CHU Amiens-Picardie
Amiens, 80054
Ousama ABOU ARAB, +33 6 22 66 24 84, abouao@gmail.com
Ousama ABOU ARAB
- Not yet recruiting
CHU de Dijon
Dijon, 21000
Pierre Grégoire GUINOT, +33 645871619, guinotpierregregoire@gmail.com
Pierre Grégoire GUINOT
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Thibaut WIPF, +33 3 69 55 12 64, thibaut.wipf@chru-strasbourg.fr
Thibaut WIPF
About this study
Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect.
The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal perfusion and function in congestive ICU patients.
It could in fine lead to a better identification of patients that could benefit from diuretic therapy in the ICU.
- Conditions
- Renal Congestion
- Being tested
- non applicable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non applicableOther
non applicable
| Study group | Role | What they receive |
|---|---|---|
| Patients with renal congestion | Not described Receives: Other: non applicable | |
| Patients without renal congestion | Not described Receives: Other: non applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of diuretics
Evaluation of renal perfusion diuretic treatment by measuring the renal resistance index and the renal venous impedance index.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Dec 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CongestionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704844
- Sponsor's protocol ID
- 7148
- Acronym
- ECHOFURO
- Status last verified
- Apr 2019
- First submitted
- 30 Jul 2018
- Last updated
- 1 May 2019
- 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 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU
- ClinicalTrials.gov ID
- NCT03704844
- Acronym / sponsor ID
- ECHOFURO / 7148
- Conditions
- Renal Congestion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Oct 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.
Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect.
The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal perfusion and function in congestive ICU patients.
It could in fine lead to a better identification of patients that could benefit from diuretic therapy in the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with renal congestion | – | Other: non applicable |
| Patients without renal congestion | – | Other: non applicable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients under treatment by furosemide
Key inclusion criteria (2 listed)
- patient hospitalized in ICU
- under furosemide treatment
Key exclusion criteria (7 listed)
- participation refusal
- uncontrolled shock (MAP<65mmHg)
- abdominal compartment syndrome
- diuretic administration in the 6 hours prior to inclusion
- renal replacement therapy or stage 4-5 chronic kidney disease
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 |
|---|---|---|
| non applicablenon applicable | Other | Patients with renal congestion, Patients without renal congestion |
Primary outcome
Effects of diuretics
Time frame: 24 hours
Evaluation of renal perfusion diuretic treatment by measuring the renal resistance index and the renal venous impedance index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
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Evaluation of the Association Between the VEXUS Score and Hemodynamic Status and the Occurrence of Acute Kidney Injury After Open-Heart Surgery
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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.
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Congestion, run by University Hospital, Strasbourg, France 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 May 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of diuretics (time frame: 24 hours). 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 1 May 2019.