Clinical Trials Directory

Trials / Unknown

UnknownNCT03478176

Intraabdominal Hypertension After Kidney Transplantation

Intraabdominal Hypertension After Kidney Transplantation : Incidence and Associated Factors

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
CHU de Reims · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2017-05-08
Primary completion
2019-05-08
Completion
2019-11-08
First posted
2018-03-27
Last updated
2018-03-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03478176. Inclusion in this directory is not an endorsement.