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

Lawson Health Research Institute

Status: Unknown

Conditions: Abdominal Compartment Syndrome; Intra-Abdominal Hypertension

Treatments: Diagnostic Test: Intra-abdominal Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03876418

100281

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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750 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

Aggressive

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Intra-abdominal Pressure