NCT01230255

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

3.4 years

First QC Date

October 28, 2010

Last Update Submit

October 28, 2010

Conditions

Compartment Syndromes

Keywords

intra-abdominal pressureintra-abdominal hypertensionabdominal compartment syndromeopen abdomenpercutaneous

Outcome Measures

Primary Outcomes (1)

  • Reduction in intra-abdominal pressure

    4 hours

Secondary Outcomes (2)

  • Increased abdominal perfusion pressure

    4 hours

  • Percutaneous drainage failure rate

    7 days

Study Arms (2)

Percutaneous catheter decompression

EXPERIMENTAL

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

Procedure: Percutaneous catheter drainage

Open abdominal decompression

ACTIVE COMPARATOR

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

Procedure: Percutaneous catheter drainage

Interventions

Percutaneous catheter drainagePROCEDURE

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 decompressionPercutaneous catheter decompression

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated intra-abdominal pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Compartment SyndromesIntra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michael L Cheatham, MD

    Orlando Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2010

First Posted

October 29, 2010

Study Start

January 1, 2007

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

October 29, 2010

Record last verified: 2010-10

Locations

US(1)