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OpenTrials
Completed

NCT Number: NCT02514135

Intra-abdominal Hypertension in Critically Ill Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Victoria Hospital

London, Ontario, N6K 1C2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Mortality

    Time frame: While patient in-hospital, expected stay one week on average

    As measured prospectively by patient death in the ICU

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2015
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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