Intraabdominal Hypertension After Kidney Transplantation

NCT ID: NCT03478176

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2019-11-08

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.

Detailed Description

Intraabdominal hypertension (IAH) is a frequent and severe condition affecting 30 to 54% of intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IAH is defined by IVP elevation above 12mmHg. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury (AKI)is the most frequent and described complication of IAH condition. IAH related AKI traduces renal hypoperfusion and its severity seems to correlate with IVP levels.

Patients undergoing kidney transplantation have several risk factors to develop IAH : abdominal wall surgery, acidosis and hypervolemic resuscitation. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.

We aim to study IAH incidence in post kidney transplantation period. Thus, we want to identify associated factors with IAH development in this context. We also aim to correlate IVP early evolution with extra-cellular hydration status evolution. Finally, impact of IAH on renal function recovery will be investigated.

Presupposing that 50 kidney transplantations per year will take place in University Hospital of Reims (France), we attend to include about 100 patients in this study. With a prevalence of at least 30% of IAH prevalence (as reported in intensive care units cohorts), enrollment of 100 patients will permit to estimate IAH prevalence with a 9% precision (with a 95%IC).

Conditions

Intraabdominal Hypertension; Kidney Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Minor ;
• Protected by the law.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damien JOLLY

Reims, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alexandre DEBRUMETZ

Role: CONTACT

adebrumetz@chu-reims.fr

0326787641 ext. 0033

Vincent DUPONT

Role: CONTACT

vdupont@chu-reims.fr

Facility Contacts

Alexandre DEBRUMETZ

Role: primary

adebrumetz@chu-reims.fr

References

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.

Reference Type: DERIVED

PMID: 32678426 (View on PubMed)

Other Identifiers

PZ17048

Identifier Type: -

Identifier Source: org_study_id