Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Primary Purpose
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intra-abdominal Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Intra-Abdominal Hypertension
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual Care
Aggressive
Arm Description
Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care.
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.
Outcomes
Primary Outcome Measures
Mortality
ICU Mortality
Secondary Outcome Measures
% of bladder pressure measurements (feasibility)
Number of eligible measurements recorded / Number of eligible measurements
Length of stay
Full Information
NCT ID
NCT03876418
First Posted
January 17, 2019
Last Updated
March 13, 2019
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03876418
Brief Title
Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Official Title
Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care.
Arm Title
Aggressive
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intra-abdominal Pressure
Intervention Description
Aggressive screening, prevention and treatment of intra-abdominal hypertension
Primary Outcome Measure Information:
Title
Mortality
Description
ICU Mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
% of bladder pressure measurements (feasibility)
Description
Number of eligible measurements recorded / Number of eligible measurements
Time Frame
30 days
Title
Length of stay
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Ball, MD
Phone
519-685-8500
Ext
71513
Email
Ian.Ball@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Ball, MD
Organizational Affiliation
London Health Sciences Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
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