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

Phase 3

Completed

• Conditions: Compartment Syndromes
• Interventions: Procedure: Percutaneous catheter drainage

• Registration Number: NCT01230255
• Lead Sponsor: Orlando Regional Medical Center

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Status Verified: 2010-10
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Last Update Submitted: 2010-10-28
• Study First Posted: 2010-10-29
• Last Update Posted: 2010-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Elevated intra-abdominal pressure

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous catheter decompression	Percutaneous catheter drainage	Ultrasound guided percutaneous catheter drainage of free intra-peritoneal fluid or blood
Open abdominal decompression	Percutaneous catheter drainage	Surgical treatment of elevated intra-abdominal pressure through traditional open abdominal decompression

Primary Outcome Measures

Name	Time	Method
Reduction in intra-abdominal pressure	4 hours

Secondary Outcome Measures

Name	Time	Method
Increased abdominal perfusion pressure	4 hours
Percutaneous drainage failure rate	7 days

Trial Locations

Locations (1)

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States