跳至主要内容
临床试验/NCT03876418
NCT03876418Unknown不适用

Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study

Lawson Health Research Institute0 个研究点目标入组 750 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
750
主要终点
Mortality

研究概览

简要总结

This study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in ICU patients. In the first two months patients will be screened and undergo usual care. In the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.

详细描述

Elevated intra-abdominal pressures or intra-abdominal hypertension (IAH) has been shown to be common in all intensive care unit (ICU) patients (upwards of 50%) and has been suggested as the missing link in multi-organ dysfunction, and subsequently ICU mortality. Despite guidelines advocating prevention and surveillance of IAH, adherence remains low in most ICUs across North America and Europe.

The creation of the World Society of the Abdominal Compartment Syndrome (WSACS) in 2004 improved the recognition of IAH/ACS by intensivists. The first consensus guidelines from the WSACS were released in 2006, followed by a 2013 update. Additionally, clinical practice guidelines and recommendations for research were released in 2007 and 2009 respectively, which attempted to standardize research methods and reporting. Unfortunately, even in the 2013 guidelines only WEAK recommendations (by GRADE methodology) could be made regarding the efficacy of surveillance and treatment of IAH/ACS, citing a lack of high quality interventional trials.

The investigator's study aims to assess the feasibility of a larger multi-center interventional trial to investigate the efficacy of aggressive screening, prevention and treatment of IAH in ICU patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Adults (> 18 years of age)
  • Admitted to intensive care unit
  • Bladder catheter in-situ

排除标准

  • Death prior to first IAP pressure measurement
  • Pregnancy
  • Expected ICU discharge within 24 hours
  • Organ donor
  • Clinical care team or patient/substitute decision maker declines to enroll patient

研究组 & 干预措施

Usual Care

No Intervention

Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care.

Aggressive

Active Comparator

Patients undergo aggressive surveillance (q6h) if intra-abdominal pressure is elevated as well as prevention and treatment according to protocol driven guidelines adapted from the World Society of the Abdominal Compartment. This may include nasogastric decompression, limiting fluid administration, drainage of ascites, paralysis and/or abdominal decompression.

干预措施: Intra-abdominal Pressure (Diagnostic Test)

结局指标

主要结局

Mortality

时间窗: 30 days

ICU Mortality

次要结局

  • Length of stay(30 days)
  • % of bladder pressure measurements (feasibility)(30 days)

研究者

申办方类型
Other
责任方
Sponsor

相似试验