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

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).

Study Overview

• Status: Completed
• Conditions: Compartment Syndromes
• Intervention / Treatment: Procedure: Percutaneous catheter drainage

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elevated intra-abdominal pressure

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Percutaneous catheter decompression; Ultrasound guided percutaneous catheter drainage of free intra-peritoneal fluid or blood	Procedure: Percutaneous catheter drainage; Ultrasound guided insertion of a 14 French pigtail catheter to drain free intra-peritoneal fluid or blood and thereby reduce elevated intra-abdominal pressure
ACTIVE_COMPARATOR: Open abdominal decompression; Surgical treatment of elevated intra-abdominal pressure through traditional open abdominal decompression	Procedure: Percutaneous catheter drainage; Ultrasound guided insertion of a 14 French pigtail catheter to drain free intra-peritoneal fluid or blood and thereby reduce elevated intra-abdominal pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in intra-abdominal pressure	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Increased abdominal perfusion pressure	4 hours
Percutaneous drainage failure rate	7 days

Collaborators and Investigators

• Sponsor: Orlando Regional Medical Center
• Investigators: Principal Investigator: Michael L Cheatham, MD, Orlando Regional Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (ESTIMATE): October 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2010
• Last Update Submitted That Met QC Criteria: October 28, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: abdominal compartment syndrome; intra-abdominal pressure; percutaneous; open abdomen; intra-abdominal hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes
• Other Study ID Numbers: OH09.068.04