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

Primary Purpose

Compartment Syndromes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Percutaneous catheter drainage
Sponsored by
Orlando Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compartment Syndromes focused on measuring intra-abdominal pressure, intra-abdominal hypertension, abdominal compartment syndrome, open abdomen, percutaneous

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elevated intra-abdominal pressure

Exclusion Criteria:

-

Sites / Locations

  • Orlando Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Percutaneous catheter decompression

Open abdominal decompression

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduction in intra-abdominal pressure

Secondary Outcome Measures

Increased abdominal perfusion pressure
Percutaneous drainage failure rate

Full Information

First Posted
October 28, 2010
Last Updated
October 28, 2010
Sponsor
Orlando Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01230255
Brief Title
Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
Official Title
Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Orlando Regional Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compartment Syndromes
Keywords
intra-abdominal pressure, intra-abdominal hypertension, abdominal compartment syndrome, open abdomen, percutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous catheter decompression
Arm Type
Experimental
Arm Description
Ultrasound guided percutaneous catheter drainage of free intra-peritoneal fluid or blood
Arm Title
Open abdominal decompression
Arm Type
Active Comparator
Arm Description
Surgical treatment of elevated intra-abdominal pressure through traditional open abdominal decompression
Intervention Type
Procedure
Intervention Name(s)
Percutaneous catheter drainage
Intervention Description
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 Measure Information:
Title
Reduction in intra-abdominal pressure
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Increased abdominal perfusion pressure
Time Frame
4 hours
Title
Percutaneous drainage failure rate
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elevated intra-abdominal pressure Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Cheatham, MD
Organizational Affiliation
Orlando Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

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

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