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

NCT ID: NCT01230255

Last Updated: 2010-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Compartment Syndromes

Keywords

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intra-abdominal pressure intra-abdominal hypertension abdominal compartment syndrome open abdomen percutaneous

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous catheter decompression

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

Group Type EXPERIMENTAL

Percutaneous catheter drainage

Intervention Type PROCEDURE

Ultrasound guided insertion of a 14 French pigtail catheter to drain free intra-peritoneal fluid or blood and thereby reduce elevated intra-abdominal pressure

Open abdominal decompression

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

Group Type ACTIVE_COMPARATOR

Percutaneous catheter drainage

Intervention Type PROCEDURE

Ultrasound guided insertion of a 14 French pigtail catheter to drain free intra-peritoneal fluid or blood and thereby reduce elevated intra-abdominal pressure

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elevated intra-abdominal pressure

Exclusion Criteria

\-
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Orlando Health

Principal Investigators

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Michael L Cheatham, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Regional Medical Center

Locations

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Orlando Regional Medical Center

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OH09.068.04

Identifier Type: -

Identifier Source: org_study_id