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

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

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.

Study Overview

• Status: Unknown
• Conditions: Intra-Abdominal Hypertension; Abdominal Compartment Syndrome
• Intervention / Treatment: Diagnostic test: Intra-abdominal Pressure

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 Type: Interventional
• Enrollment (Anticipated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ian Ball, MD; Phone Number: 71513 519-685-8500; Email: Ian.Ball@lhsc.on.ca

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	ICU Mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay		30 days
% of bladder pressure measurements (feasibility)	Number of eligible measurements recorded / Number of eligible measurements	30 days

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Ian Ball, MD, London Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Hypertension; Syndrome; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: 100281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No