Intra-Abdominal HypertensionNCT02514135
Intra-abdominal Hypertension in Critically Ill Patients
An observational study of Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by Western University, Canada at 1 site in Canada.
Trial summary
The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
- How many people
- 286 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2015to 30 May 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults (>18 years of age) admitted to the intensive care unit at Victoria Hospital, London, Ontario who have a Foley catheter in-situ
Who may be able to join
- Foley catheter in-situ on admission
Who cannot join
- Contra-indication to bladder pressure measurement
- Home service asked that patient is not included
- Death within 24 priors of admission before bladder pressure measured
- No bladder pressure performed within 24 hours of admission
- Consent refused or unable to be obtained (lack of SDM, patient unable to provide)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.
Read the detailed description
Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.
- Being tested
- No intervention
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Elevated Intra-abdominal Pressure | Patients with intra-abdominal pressure > 12 mmHg at any time throughout admission Receives: Other: No intervention | |
| Normal Intra-abdominal Pressure | Patients with intra-abdominal pressure < 12 mmHg throughout admission Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
As measured prospectively by patient death in the ICU
Measured: While patient in-hospital, expected stay one week on average
Secondary outcomes (2)
Length of stay
Measured prospectively from date of admission to ICU to death, or discharge from ICU
Measured: While patient in-hospital, expected stay one week on average
Abdominal decompression
Midline laparotomy for abdominal compartment syndrome
Measured: While patient in-hospital, expected stay one week on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start1 Sep 2015
- Primary completion30 Jan 2016
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Murphy, Western University, Canada
- Investigators
- Kelly N Vogt, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514135
- Sponsor's protocol ID
- WesternUCanada
- Status last verified
- Aug 2018
- First submitted
- 30 Jul 2015
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
PubMed 23673399
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-abdominal Hypertension in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02514135
- Acronym / sponsor ID
- WesternUCanada
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Jan 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 3 Aug 2015 (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.
The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.
Detailed description
Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elevated Intra-abdominal Pressure | – | Other: No interventionPatients with intra-abdominal pressure > 12 mmHg at any time throughout admission |
| Normal Intra-abdominal Pressure | – | Other: No interventionPatients with intra-abdominal pressure < 12 mmHg throughout admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults (>18 years of age) admitted to the intensive care unit at Victoria Hospital, London, Ontario who have a Foley catheter in-situ
Key inclusion criteria (1 listed)
- Foley catheter in-situ on admission
Key exclusion criteria (5 listed)
- Contra-indication to bladder pressure measurement
- Home service asked that patient is not included
- Death within 24 priors of admission before bladder pressure measured
- No bladder pressure performed within 24 hours of admission
- Consent refused or unable to be obtained (lack of SDM, patient unable to provide)
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 |
|---|---|---|
| No intervention | Other | Elevated Intra-abdominal Pressure, Normal Intra-abdominal Pressure |
Primary outcome
Mortality
Time frame: While patient in-hospital, expected stay one week on average
As measured prospectively by patient death in the ICU
2 secondary outcomes
Length of stay
Time frame: While patient in-hospital, expected stay one week on average
Abdominal decompression
Time frame: While patient in-hospital, expected stay one week on average
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 27 Aug 2018.
- Background: PubMed 23673399Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
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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.
Kelly N Vogt, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by Western University, Canada at 1 site in Canada.
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 5 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 27 Aug 2018. 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 Canada. 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.
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?
Mortality (time frame: While patient in-hospital, expected stay one week on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514135, which also lists 1 linked publication.
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 27 Aug 2018.