Intraabdominal Hypertension After Kidney Transplantation

Kidney Transplantation Clinical Trial

— KITIV  

Official title:

Intraabdominal Hypertension After Kidney Transplantation : Incidence and Associated Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03478176
• Other study ID #: PZ17048
• Status: Recruiting
• First received: February 1, 2018
• Last updated: March 23, 2018
• Start date: May 8, 2017
• Est. completion date: November 8, 2019

Study information

• Verified date: February 2018
• Source: CHU de Reims
• Contact: Alexandre DEBRUMETZ
• Phone: 0326787641
• Email: adebrumetz[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 8, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Intra-Abdominal Hypertension
• Intraabdominal Hypertension
• Kidney Transplantation

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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