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

NCT ID: NCT03876418

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-07-01

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.

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.

Conditions

Intra-Abdominal Hypertension; Abdominal Compartment Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Intra-abdominal Pressure

Intervention Type: DIAGNOSTIC_TEST

Aggressive screening, prevention and treatment of intra-abdominal hypertension

Interventions

Intra-abdominal Pressure

Aggressive screening, prevention and treatment of intra-abdominal hypertension

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Ball, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Center

Central Contacts

Ian Ball, MD

Role: CONTACT

Ian.Ball@lhsc.on.ca

519-685-8500 ext. 71513

Other Identifiers

100281

Identifier Type: -

Identifier Source: org_study_id