Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01230255
Status:
COMPLETED
Last Update Posted:
2010-10-29
First Post:
2010-10-28
Brief Title:
Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
Sponsor:
Orlando Regional Medical Center
Organization:
Orlando Regional Medical Center
Study Overview
Official Title:
Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1012 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
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 1012 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None