NCT04682236

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

December 18, 2020

Last Update Submit

December 23, 2020

Conditions

Keywords

Acute Renal FailureChronic renal failureLiver transplantRenal vascular profilesIntraoperative hemodynamic instabilityAcute tubular necrosisRenal doppler

Outcome Measures

Primary Outcomes (1)

  • Retrospective analysis of the development profiles of renal dopplers in perioperative liver transplantation

    Files analysed retrospectily from July 1st, 2019 to June 30, 2020 will be examined

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient operated on at the HUS for a liver transplant, between July 1, 2019 and June 30, 2020

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strasbourg University Hospitals - Anesthesia-intensive care unit

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney InjuryKidney Failure, ChronicKidney Cortex Necrosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julien POTTECHER, MD, PhD

    Strasbourg University Hospitals - Anesthesia-intensive care unit

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2020

First Posted

December 23, 2020

Study Start

November 25, 2020

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

December 28, 2020

Record last verified: 2020-12

Locations