Intra-abdominal Hypertension in Critically Ill Patients

Completed

• Conditions: Abdominal Compartment Syndrome; Intra-Abdominal Hypertension
• Interventions: Other: No intervention

• Registration Number: NCT02514135
• Lead Sponsor: Western University, Canada

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.

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 Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-08-03
• Study Start: 2015-09-01
• Primary Completion: 2016-01-30
• Study Completion: 2016-05-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Intra-abdominal Pressure	No intervention	Patients with intra-abdominal pressure \< 12 mmHg throughout admission
Elevated Intra-abdominal Pressure	No intervention	Patients with intra-abdominal pressure \> 12 mmHg at any time throughout admission

Primary Outcome Measures

Name	Time	Method
Mortality	While patient in-hospital, expected stay one week on average	As measured prospectively by patient death in the ICU

Secondary Outcome Measures

Name	Time	Method
Length of stay	While patient in-hospital, expected stay one week on average	Measured prospectively from date of admission to ICU to death, or discharge from ICU
Abdominal decompression	While patient in-hospital, expected stay one week on average	Midline laparotomy for abdominal compartment syndrome

Trial Locations

Locations (1)

Victoria Hospital; 🇨🇦 London, Ontario, Canada