Intra-abdominal Hypertension in Critically Ill Patients

• ClinicalTrials.gov Identifier: NCT02514135
• Recruitment Status: Completed
• First Posted: August 3, 2015
• Last Update Posted: August 27, 2018
• Sponsor: Western University, Canada
• Information provided by (Responsible Party): Patrick Murphy, Western University, Canada

Study Description

Brief Summary:

The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.

Condition or disease	Intervention/treatment
Intra-Abdominal Hypertension; Abdominal Compartment Syndrome	Other: No intervention

Detailed Description:

Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.

Study Design

• Study Type: Observational
• Estimated Enrollment: 286 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intra-abdominal Hypertension in Critically Ill Patients
• Actual Study Start Date: September 1, 2015
• Actual Primary Completion Date: January 30, 2016
• Actual Study Completion Date: May 30, 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
Elevated Intra-abdominal Pressure; Patients with intra-abdominal pressure > 12 mmHg at any time throughout admission	Other: No intervention
Normal Intra-abdominal Pressure; Patients with intra-abdominal pressure < 12 mmHg throughout admission	Other: No intervention

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: While patient in-hospital, expected stay one week on average ]
   As measured prospectively by patient death in the ICU

Secondary Outcome Measures :

1. Length of stay [ Time Frame: While patient in-hospital, expected stay one week on average ]
   Measured prospectively from date of admission to ICU to death, or discharge from ICU
2. Abdominal decompression [ Time Frame: While patient in-hospital, expected stay one week on average ]
   Midline laparotomy for abdominal compartment syndrome

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All adults (>18 years of age) admitted to the intensive care unit at Victoria Hospital, London, Ontario who have a Foley catheter in-situ

Criteria

Inclusion Criteria:

• Foley catheter in-situ on admission

Exclusion Criteria:

• Contra-indication to bladder pressure measurement
• Home service asked that patient is not included
• Death within 24 priors of admission before bladder pressure measured
• No bladder pressure performed within 24 hours of admission
• Consent refused or unable to be obtained (lack of SDM, patient unable to provide)

Contacts and Locations

Locations

Canada, Ontario

Victoria Hospital

London, Ontario, Canada, N6K 1C2

Sponsors and Collaborators

Western University, Canada

Investigators

• Principal Investigator: Kelly N Vogt, MD; Western University

More Information

Publications:

Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.

• Responsible Party: Patrick Murphy, Resident, Western University, Canada
• ClinicalTrials.gov Identifier: NCT02514135
• Other Study ID Numbers: WesternUCanada
• First Posted: August 3, 2015
• Last Update Posted: August 27, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Compartment Syndromes; Intra-Abdominal Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases