Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome

Intra-Abdominal Hypertension Clinical Trial

Official title:

Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03876418
• Other study ID #: 100281
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Compartment Syndromes
• Hypertension
• Intra-Abdominal Hypertension
• Syndrome

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