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临床试验/NCT03478176
NCT03478176Unknown不适用

Intraabdominal Hypertension After Kidney Transplantation : Incidence and Associated Factors

CHU de Reims1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
100
试验地点
1
主要终点
Intraabdominal hypertension Intraabdominal pressure

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Protected by the law.

结局指标

主要结局

Intraabdominal hypertension Intraabdominal pressure

时间窗: day 5

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

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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