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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01230255
Other study ID # OH09.068.04
Secondary ID
Status Completed
Phase Phase 3
First received October 28, 2010
Last updated October 28, 2010
Start date January 2007
Est. completion date August 2010

Study information

Verified date October 2010
Source Orlando Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Description:

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Orlando Regional Medical Center Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Orlando Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in intra-abdominal pressure 4 hours No
Secondary Increased abdominal perfusion pressure 4 hours No
Secondary Percutaneous drainage failure rate 7 days No
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