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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
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra-Abdominal Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    January 17, 2019
    Last Updated
    March 13, 2019
    Sponsor
    Lawson Health Research Institute
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    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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