Acute Renal FailureDOP-RENALNCT04682236
Study of the Evolution Profile of the Renal Doppler in the Perioperative Hepathic Transplantation
An observational study of Acute Renal Failure, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Liver transplantation is associated with a modification of the perfusion pressures of the abdominal organs (preoperative portal hypertension in connection with liver pathology, and normalization of the perfusion pressures during surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2020to 25 May 2022
- 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: Adult patient operated on at the HUS for a liver transplant, between July 1, 2019 and June 30, 2020
Who may be able to join
- Patient of full age (≥18 years)
- Patient operated on at the HUS for a liver transplant, between July 1, 2019 and June 30, 2020.
- Patients having undergone an evaluation of hepatic and renal vascular profiles perioperatively.
- Patients hospitalized in the surgical intensive care unit after hepatic transplant surgery.
- Patient not having expressed, after information, the reuse of his data for the purposes of this research
Who cannot join
- Patient who expressed his opposition to participating in the study
- Patient with suspected obstructive acute renal failure
- Stenosis of renal arteries known at the time
- End-stage renal disease on dialysis
- Impossibility of giving the subject informed information (difficulties in understanding the subject, etc.)
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Strasbourg University Hospitals - Anesthesia-intensive care unit
Strasbourg, 67091
Julien POTTECHER, MD, PhD, 33 3 88 12 70 95, julien.pottecher@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Study of the Evolution Profile of the Renal Doppler in the Perioperative Hepathic Transplantation - Interest in Predicting the Occurence of Acute Postoperative Renal Faillure
Liver transplantation is associated with a modification of the perfusion pressures of the abdominal organs (preoperative portal hypertension in connection with liver pathology, and normalization of the perfusion pressures during surgery). This abrupt change in the infusion regime is probably responsible for an alteration in renal function in some patients, and the identification of renal vascular profiles using Doppler could point to pathological profiles, which should be diagnosed early.
- Conditions
- Acute Renal Failure
- Keywords
- Acute Renal Failure, Chronic renal failure, Liver transplant, Renal vascular profiles, Intraoperative hemodynamic instability, Acute tubular necrosis, Renal doppler
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic, Kidney Cortex Necrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of the development profiles of renal dopplers in perioperative liver transplantation
Measured: Files analysed retrospectily from July 1st, 2019 to June 30, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start25 Nov 2020
- Primary completion25 May 2022 (estimated)
- Study completion25 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien POTTECHER, MD, PhD, Study director, Strasbourg University Hospitals - Anesthesia-intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682236
- Sponsor's protocol ID
- 8059
- Acronym
- DOP-RENAL
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Evolution Profile of the Renal Doppler in the Perioperative Hepathic Transplantation - Interest in Predicting the Occurence of Acute Postoperative Renal Faillure
- ClinicalTrials.gov ID
- NCT04682236
- Acronym / sponsor ID
- DOP-RENAL / 8059
- Conditions
- Acute Renal Failure
- Keywords
- Acute Renal Failure, Chronic renal failure, Liver transplant, Renal vascular profiles, Intraoperative hemodynamic instability, Acute tubular necrosis, Renal doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 25 May 2022 (estimated)
- Study completion
- 25 May 2022 (estimated)
- First posted
- 23 Dec 2020 (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.
Liver transplantation is associated with a modification of the perfusion pressures of the abdominal organs (preoperative portal hypertension in connection with liver pathology, and normalization of the perfusion pressures during surgery). This abrupt change in the infusion regime is probably responsible for an alteration in renal function in some patients, and the identification of renal vascular profiles using Doppler could point to pathological profiles, which should be diagnosed early.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient operated on at the HUS for a liver transplant, between July 1, 2019 and June 30, 2020
Key inclusion criteria (5 listed)
- Patient of full age (≥18 years)
- Patient operated on at the HUS for a liver transplant, between July 1, 2019 and June 30, 2020.
- Patients having undergone an evaluation of hepatic and renal vascular profiles perioperatively.
- Patients hospitalized in the surgical intensive care unit after hepatic transplant surgery.
- Patient not having expressed, after information, the reuse of his data for the purposes of this research
Key exclusion criteria (6 listed)
- Patient who expressed his opposition to participating in the study
- Patient with suspected obstructive acute renal failure
- Stenosis of renal arteries known at the time
- End-stage renal disease on dialysis
- Impossibility of giving the subject informed information (difficulties in understanding the subject, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective analysis of the development profiles of renal dopplers in perioperative liver transplantation
Time frame: Files analysed retrospectily from July 1st, 2019 to June 30, 2020 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
Related trials for Acute Renal Failure
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Julien POTTECHER, MD, PhD study director
Strasbourg University Hospitals - Anesthesia-intensive care unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure, run by University Hospital, Strasbourg, France at 1 site 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 5 inclusion and 6 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 28 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 1 site 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?
Contact Julien POTTECHER, MD, PhD (33 3 88 12 70 95, julien.pottecher@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of the development profiles of renal dopplers in perioperative liver transplantation (time frame: Files analysed retrospectily from July 1st, 2019 to June 30, 2020 will be examined). 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 28 Dec 2020.