Intra-Abdominal HypertensionNCT03876418
Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
A study testing Intra-abdominal Pressure in people with Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
This study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in ICU patients. In the first two months patients will be screened and undergo usual care. 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
- What is being tested?
- Intra-abdominal Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adults (> 18 years of age)
- Admitted to intensive care unit
- Bladder catheter in-situ
Who cannot join
- Death prior to first IAP pressure measurement
- Pregnancy
- Expected ICU discharge within 24 hours
- Organ donor
- Clinical care team or patient/substitute decision maker declines to enroll patient
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study
This study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in ICU patients. In the first two months patients will be screened and undergo usual care. In the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.
Read the detailed description
Elevated intra-abdominal pressures or intra-abdominal hypertension (IAH) has been shown to be common in all intensive care unit (ICU) patients (upwards of 50%) and has been suggested as the missing link in multi-organ dysfunction, and subsequently ICU mortality. Despite guidelines advocating prevention and surveillance of IAH, adherence remains low in most ICUs across North America and Europe.
The creation of the World Society of the Abdominal Compartment Syndrome (WSACS) in 2004 improved the recognition of IAH/ACS by intensivists. The first consensus guidelines from the WSACS were released in 2006, followed by a 2013 update. Additionally, clinical practice guidelines and recommendations for research were released in 2007 and 2009 respectively, which attempted to standardize research methods and reporting. Unfortunately, even in the 2013 guidelines only WEAK recommendations (by GRADE methodology) could be made regarding the efficacy of surveillance and treatment of IAH/ACS, citing a lack of high quality interventional trials.
The investigator's study aims to assess the feasibility of a larger multi-center interventional trial to investigate the efficacy of aggressive screening, prevention and treatment of IAH in ICU patients.
- Being tested
- Intra-abdominal Pressure
- 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.
Intra-abdominal PressureDiagnostic test
Aggressive screening, prevention and treatment of intra-abdominal hypertension
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care. |
| Aggressive | Active comparator | Patients undergo aggressive surveillance (q6h) if intra-abdominal pressure is elevated as well as prevention and treatment according to protocol driven guidelines adapted from the World Society of the Abdominal Compartment. This may include nasogastric decompression, limiting fluid administration, drainage of ascites, paralysis and/or abdominal decompression. Receives: Diagnostic Test: Intra-abdominal Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
ICU Mortality
Measured: 30 days
Secondary outcomes (2)
% of bladder pressure measurements (feasibility)
Number of eligible measurements recorded / Number of eligible measurements
Measured: 30 days
Length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 May 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Ball, MD, Principal investigator, London Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876418
- Sponsor's protocol ID
- 100281
- Status last verified
- Mar 2019
- First submitted
- 17 Jan 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03876418
- Acronym / sponsor ID
- 100281
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 15 Mar 2019 (actual)
- 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.
This study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in ICU patients. In the first two months patients will be screened and undergo usual care. In the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.
Detailed description
Elevated intra-abdominal pressures or intra-abdominal hypertension (IAH) has been shown to be common in all intensive care unit (ICU) patients (upwards of 50%) and has been suggested as the missing link in multi-organ dysfunction, and subsequently ICU mortality. Despite guidelines advocating prevention and surveillance of IAH, adherence remains low in most ICUs across North America and Europe.
The creation of the World Society of the Abdominal Compartment Syndrome (WSACS) in 2004 improved the recognition of IAH/ACS by intensivists. The first consensus guidelines from the WSACS were released in 2006, followed by a 2013 update. Additionally, clinical practice guidelines and recommendations for research were released in 2007 and 2009 respectively, which attempted to standardize research methods and reporting. Unfortunately, even in the 2013 guidelines only WEAK recommendations (by GRADE methodology) could be made regarding the efficacy of surveillance and treatment of IAH/ACS, citing a lack of high quality interventional trials.
The investigator's study aims to assess the feasibility of a larger multi-center interventional trial to investigate the efficacy of aggressive screening, prevention and treatment of IAH in ICU patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care. |
| Aggressive | Active comparator | Diagnostic Test: Intra-abdominal PressurePatients undergo aggressive surveillance (q6h) if intra-abdominal pressure is elevated as well as prevention and treatment according to protocol driven guidelines adapted from the World Society of the Abdominal Compartment. This may include nasogastric decompression, limiting fluid administration, drainage of ascites, paralysis and/or abdominal decompression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (> 18 years of age)
- Admitted to intensive care unit
- Bladder catheter in-situ
Key exclusion criteria (5 listed)
- Death prior to first IAP pressure measurement
- Pregnancy
- Expected ICU discharge within 24 hours
- Organ donor
- Clinical care team or patient/substitute decision maker declines to enroll patient
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 |
|---|---|---|
| Intra-abdominal PressureAggressive screening, prevention and treatment of intra-abdominal hypertension | Diagnostic test | Aggressive |
Primary outcome
Mortality
Time frame: 30 days
ICU Mortality
2 secondary outcomes
% of bladder pressure measurements (feasibility)
Time frame: 30 days
Length of stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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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.
Ian Ball, MD principal investigator
London Health Sciences Center
Questions about this trial
What is this clinical trial studying?
A study testing Intra-abdominal Pressure in people with Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian Ball, MD (519-685-8500 ext. 71513, Ian.Ball@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). 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 15 Mar 2019.