An observational study in Intraabdominal Hypertension and Kidney Transplantation, sponsored by CHU de Reims. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by CHU de Reims · Observational
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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.
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).
71 studies on the registry are indexed under Intra-Abdominal Hypertension; 16 are open to participants now.
This study's planned enrollment of 100 is close to the median of 98 across 36 observational studies indexed under Intra-Abdominal Hypertension.
Browse Intra-Abdominal Hypertension studies →CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.
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Patients with chronic kidney disease undergoing kidney transplantation in University Hospital of Reims (France)
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Exclusion Criteria:
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
Time frame: day 5
Started May 2017 (actual). Primary completion is estimated for May 2019, 24 months after the start.
Of 20 observational studies under Intra-Abdominal Hypertension, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 26. This study's planned 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Intra-Abdominal Hypertension →