Clinical trial NCT01230255: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Compartment Syndromes
Keywords: intra-abdominal pressure
intra-abdominal hypertension
abdominal compartment syndrome
open abdomen
percutaneous
Lead sponsor: Orlando Regional Medical Center
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 62
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Elevated intra-abdominal pressure

Exclusion Criteria:

-

Primary outcomes:
measure: Reduction in intra-abdominal pressure
timeFrame: 4 hours
Secondary outcomes:
measure: Increased abdominal perfusion pressure
timeFrame: 4 hours
measure: Percutaneous drainage failure rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
Study officials:
affiliation: Orlando Regional Medical Center
name: Michael L Cheatham, MD
role: PRINCIPAL_INVESTIGATOR
References: