Compartment SyndromesPhase 3NCT01230255
Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
A Phase 3 study testing Percutaneous catheter drainage in people with Compartment Syndromes, run by Orlando Regional Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Compartment Syndromes
- What is being tested?
- Percutaneous catheter drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elevated intra-abdominal pressure
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Regional Medical Center
Orlando, Florida, 32806
About this study
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).
Read the 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.
- Conditions
- Compartment Syndromes
- Being tested
- Percutaneous catheter drainage
- Keywords
- intra-abdominal pressure, intra-abdominal hypertension, abdominal compartment syndrome, open abdomen, percutaneous
- Medical subject headings
- Compartment Syndromes, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous catheter drainageProcedure or surgery
Ultrasound guided insertion of a 14 French pigtail catheter to drain free intra-peritoneal fluid or blood and thereby reduce elevated intra-abdominal pressure
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous catheter decompression | Experimental | Ultrasound guided percutaneous catheter drainage of free intra-peritoneal fluid or blood Receives: Procedure: Percutaneous catheter drainage |
| Open abdominal decompression | Active comparator | Surgical treatment of elevated intra-abdominal pressure through traditional open abdominal decompression Receives: Procedure: Percutaneous catheter drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in intra-abdominal pressure
Measured: 4 hours
Secondary outcomes (2)
Increased abdominal perfusion pressure
Measured: 4 hours
Percutaneous drainage failure rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startJan 2007
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Regional Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Michael L Cheatham, MD, Principal investigator, Orlando Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230255
- Sponsor's protocol ID
- OH09.068.04
- Status last verified
- Oct 2010
- First submitted
- 28 Oct 2010
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
- ClinicalTrials.gov ID
- NCT01230255
- Acronym / sponsor ID
- OH09.068.04
- Conditions
- Compartment Syndromes
- Keywords
- intra-abdominal pressure, intra-abdominal hypertension, abdominal compartment syndrome, open abdomen, percutaneous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Orlando Regional Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous catheter decompression | Experimental | Procedure: Percutaneous catheter drainageUltrasound guided percutaneous catheter drainage of free intra-peritoneal fluid or blood |
| Open abdominal decompression | Active comparator | Procedure: Percutaneous catheter drainageSurgical treatment of elevated intra-abdominal pressure through traditional open abdominal decompression |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated intra-abdominal pressure
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous catheter drainageUltrasound guided insertion of a 14 French pigtail catheter to drain free intra-peritoneal fluid or blood and thereby reduce elevated intra-abdominal pressure | Procedure or surgery | Open abdominal decompression, Percutaneous catheter decompression |
Primary outcome
Reduction in intra-abdominal pressure
Time frame: 4 hours
2 secondary outcomes
Increased abdominal perfusion pressure
Time frame: 4 hours
Percutaneous drainage failure rate
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Cheatham, MD principal investigator
Orlando Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous catheter drainage in people with Compartment Syndromes, run by Orlando Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in intra-abdominal pressure (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2010.