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

This study has been completed.
Sponsor:
Information provided by:
Orlando Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01230255
First received: October 28, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Compartment Syndromes
Procedure: Percutaneous catheter drainage
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure

Resource links provided by NLM:


Further study details as provided by Orlando Regional Medical Center:

Primary Outcome Measures:
  • Reduction in intra-abdominal pressure [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased abdominal perfusion pressure [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Percutaneous drainage failure rate [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: January 2007
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elevated intra-abdominal pressure

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230255

Locations
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Orlando Regional Medical Center
Investigators
Principal Investigator: Michael L Cheatham, MD Orlando Regional Medical Center
  More Information

No publications provided

Responsible Party: Michael L. Cheatham, MD, Orlando Health
ClinicalTrials.gov Identifier: NCT01230255     History of Changes
Other Study ID Numbers: OH09.068.04
Study First Received: October 28, 2010
Last Updated: October 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Orlando Regional Medical Center:
intra-abdominal pressure
intra-abdominal hypertension
abdominal compartment syndrome
open abdomen
percutaneous

Additional relevant MeSH terms:
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014