Intra-abdominal Hypertension in Critically Ill Patients

Intra-Abdominal Hypertension Clinical Trial

Official title:

Intra-abdominal Hypertension in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514135
• Other study ID #: WesternUCanada
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: May 30, 2016

Study information

• Verified date: August 2018
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: May 30, 2016
• Est. primary completion date: January 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Compartment Syndromes
• Critical Illness
• Hypertension
• Intra-Abdominal Hypertension

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	As measured prospectively by patient death in the ICU	While patient in-hospital, expected stay one week on average
Secondary	Length of stay	Measured prospectively from date of admission to ICU to death, or discharge from ICU	While patient in-hospital, expected stay one week on average
Secondary	Abdominal decompression	Midline laparotomy for abdominal compartment syndrome	While patient in-hospital, expected stay one week on average