NCT03876418

Brief Summary

This study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in ICU patients. In the first two months patients will be screened and undergo usual care. In the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

January 17, 2019

Last Update Submit

March 13, 2019

Conditions

Intra-Abdominal HypertensionAbdominal Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

  • Mortality

    ICU Mortality

    30 days

Secondary Outcomes (2)

  • % of bladder pressure measurements (feasibility)

    30 days

  • Length of stay

    30 days

Study Arms (2)

Usual Care

NO INTERVENTION

Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care.

Aggressive

ACTIVE COMPARATOR

Patients undergo aggressive surveillance (q6h) if intra-abdominal pressure is elevated as well as prevention and treatment according to protocol driven guidelines adapted from the World Society of the Abdominal Compartment. This may include nasogastric decompression, limiting fluid administration, drainage of ascites, paralysis and/or abdominal decompression.

Diagnostic Test: Intra-abdominal Pressure

Interventions

Intra-abdominal PressureDIAGNOSTIC_TEST

Aggressive screening, prevention and treatment of intra-abdominal hypertension

Aggressive

Eligibility Criteria

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

You may qualify if:

  • Adults (\> 18 years of age)
  • Admitted to intensive care unit
  • Bladder catheter in-situ

You may not qualify if:

  • Death prior to first IAP pressure measurement
  • Pregnancy
  • Expected ICU discharge within 24 hours
  • Organ donor
  • Clinical care team or patient/substitute decision maker declines to enroll patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ian Ball, MD

    London Health Sciences Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Ball, MD

CONTACT

519-685-8500Ian.Ball@lhsc.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

March 15, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

March 15, 2019

Record last verified: 2019-03