NCT02514135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

July 30, 2015

Last Update Submit

August 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    As measured prospectively by patient death in the ICU

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

Secondary Outcomes (2)

  • Length of stay

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

  • Abdominal decompression

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

Study Arms (2)

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

Interventions

Elevated Intra-abdominal PressureNormal Intra-abdominal Pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Foley catheter in-situ on admission

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6K 1C2, Canada

Location

Related 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.

    PMID: 23673399BACKGROUND

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kelly N Vogt, MD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 3, 2015

Study Start

September 1, 2015

Primary Completion

January 30, 2016

Study Completion

May 30, 2016

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations