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临床试验/NCT01230255
NCT01230255已完成3 期

Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure

Orlando Regional Medical Center1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2007年1月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
62
试验地点
1
主要终点
Reduction in intra-abdominal pressure

研究概览

简要总结

Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have traditionally been treated surgically through emergent laparotomy. Intensivist-performed bedside drainage of free intra-peritoneal fluid or blood [percutaneous catheter decompression (PCD)] has been suggested as a less-invasive alternative to traditional open abdominal decompression (OAD). This study assesses the relative efficacy of PCD vs. OAD in reducing elevated intra-abdominal pressure (IAP).

详细描述

Intra-abdominal hypertension (IAH), the presence of elevated intra-abdominal pressure (IAP), and abdominal compartment syndrome (ACS), the development of IAH-induced organ-dysfunction and failure, are both associated with significant morbidity and mortality when appropriate and expedient treatment is not rendered. Elevated IAP is an independent predictor of mortality during critical illness and serial IAP measurements are increasingly being performed in the intensive care unit (ICU) setting.

Despite growing evidence demonstrating the survival benefit of serial IAP monitoring and abdominal decompression in patients with IAH / ACS, some physicians are reluctant to consider decompression or unable to convince a surgeon to open the abdomen of patients manifesting IAH-related organ failure. Percutaneous catheter drainage (PCD) of free intra-abdominal fluid, air, abscess, or blood has been suggested in several case reports and small clinical trials to be a less invasive technique for reducing IAP and potentially correcting IAH-induced organ dysfunction. PCD, performed under ultrasound or computed tomography guidance, is described in the current World Society of the Abdominal Compartment Syndrome (WSACS) consensus recommendations as a therapeutic option, but insufficient data currently exist to support a strong evidence-based recommendation for the percutaneous treatment of IAH / ACS (10,12). Since 2007, we have employed PCD in the treatment of patients with IAH due to free intraperitoneal fluid and blood. This study describes our experience with the less invasive PCD technique compared to contemporaneous matched control patients who received traditional open abdominal decompression (OAD) for the treatment of IAH / ACS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Elevated intra-abdominal pressure

排除标准

  • 未提供

研究组 & 干预措施

Open abdominal decompression

Active Comparator

Surgical treatment of elevated intra-abdominal pressure through traditional open abdominal decompression

干预措施: Percutaneous catheter drainage (Procedure)

Percutaneous catheter decompression

Experimental

Ultrasound guided percutaneous catheter drainage of free intra-peritoneal fluid or blood

干预措施: Percutaneous catheter drainage (Procedure)

结局指标

主要结局

Reduction in intra-abdominal pressure

时间窗: 4 hours

次要结局

  • Increased abdominal perfusion pressure(4 hours)
  • Percutaneous drainage failure rate(7 days)

研究者

申办方类型
Other

研究点 (1)

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