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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230255
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : October 29, 2010
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Compartment Syndromes Procedure: Percutaneous catheter drainage Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
Study Start Date : January 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Reduction in intra-abdominal pressure [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Increased abdominal perfusion pressure [ Time Frame: 4 hours ]
  2. Percutaneous drainage failure rate [ Time Frame: 7 days ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elevated intra-abdominal pressure

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230255


Locations
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United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Orlando Regional Medical Center
Investigators
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Principal Investigator: Michael L Cheatham, MD Orlando Regional Medical Center
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Responsible Party: Michael L. Cheatham, MD, Orlando Health
ClinicalTrials.gov Identifier: NCT01230255    
Other Study ID Numbers: OH09.068.04
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: October 29, 2010
Last Verified: October 2010
Keywords provided by Orlando Regional Medical Center:
intra-abdominal pressure
intra-abdominal hypertension
abdominal compartment syndrome
open abdomen
percutaneous
Additional relevant MeSH terms:
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Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases