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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03876418
Other study ID # 100281
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date July 1, 2020

Study information

Verified date March 2019
Source Lawson Health Research Institute
Contact Ian Ball, MD
Phone 519-685-8500
Email Ian.Ball@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. In the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 750
Est. completion date July 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults (> 18 years of age)

- Admitted to intensive care unit

- Bladder catheter in-situ

Exclusion Criteria:

- 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

Study Design


Intervention

Diagnostic Test:
Intra-abdominal Pressure
Aggressive screening, prevention and treatment of intra-abdominal hypertension

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality ICU Mortality 30 days
Secondary % of bladder pressure measurements (feasibility) Number of eligible measurements recorded / Number of eligible measurements 30 days
Secondary Length of stay 30 days
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