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

• ClinicalTrials.gov Identifier: NCT03876418
• Recruitment Status: Unknown
• First Posted: March 15, 2019
• Last Update Posted: March 15, 2019
• Sponsor: Lawson Health Research Institute
• Information provided by (Responsible Party): Lawson Health Research Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Intra-Abdominal Hypertension; Abdominal Compartment Syndrome	Diagnostic Test: Intra-abdominal Pressure	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 750 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study
• Estimated Study Start Date: May 1, 2019
• Estimated Primary Completion Date: May 1, 2020
• Estimated Study Completion Date: July 1, 2020

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual Care; Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care.
Active Comparator: Aggressive; 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.	Diagnostic Test: Intra-abdominal Pressure; Aggressive screening, prevention and treatment of intra-abdominal hypertension

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: 30 days ]
   ICU Mortality

Secondary Outcome Measures :

1. % of bladder pressure measurements (feasibility) [ Time Frame: 30 days ]
   Number of eligible measurements recorded / Number of eligible measurements
2. Length of stay [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Ian Ball, MD; 519-685-8500 ext 71513; Ian.Ball@lhsc.on.ca

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

• Principal Investigator: Ian Ball, MD; London Health Sciences Center

More Information

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT03876418
• Other Study ID Numbers: 100281
• First Posted: March 15, 2019
• Last Update Posted: March 15, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Compartment Syndromes; Intra-Abdominal Hypertension; Hypertension; Syndrome; Disease; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases