NCT03478176

Brief Summary

Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury is the most frequent and described complication of IAH condition. Patients undergoing kidney transplantation have several risk factors to develop IAH. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown. We aim to study IAH incidence, associated factors and impact on renal function recovery in post kidney transplantation period.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2019

Completed
Last Updated

March 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 1, 2018

Last Update Submit

March 23, 2018

Conditions

Keywords

Intraabdominal hypertensionKidney transplantation

Outcome Measures

Primary Outcomes (1)

  • Intraabdominal hypertension Intraabdominal pressure

    Intraabdominal pressure equal or more than 12 mmHg for at least 2 measures spaced less than 24 hours. Intraabdominal pressure will be evaluated every 8 hours during the 5 days after transplantation, using UnometerTM AbdopressureTM system

    day 5

Study Arms (1)

Patients

Eligibility Criteria

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

Patients with chronic kidney disease undergoing kidney transplantation in University Hospital of Reims (France)

You may qualify if:

  • End stage chronic kidney disease ;
  • Hospitalized in intensive care of nephrology unit in University Hospital of Reims (France) during study period ;
  • Undergoing kidney transplantation ;
  • Accepting to participate.

You may not qualify if:

  • Minor ;
  • Protected by the law.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

Related Publications (1)

  • Dupont V, Debrumetz A, Leguillou A, Morland D, Wynckel A, Colosio C, Mokri L, Schvartz B, Vuiblet V, Larre S, Barbe C, Rieu P. Intra-abdominal hypertension in early post-kidney transplantation period is associated with impaired graft function. Nephrol Dial Transplant. 2020 Sep 1;35(9):1619-1628. doi: 10.1093/ndt/gfaa104.

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Alexandre DEBRUMETZ

CONTACT

Vincent DUPONT

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

March 27, 2018

Study Start

May 8, 2017

Primary Completion

May 8, 2019

Study Completion

November 8, 2019

Last Updated

March 27, 2018

Record last verified: 2018-02

Locations