NCT01458262

Brief Summary

The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Typical duration 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

Study Start

First participant enrolled

September 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

2.1 years

First QC Date

September 22, 2011

Last Update Submit

January 27, 2014

Conditions

Cerebral Desaturation

Keywords

cerebral oxymetrysystemic oxymetryhepatic surgeryliver transplantation

Outcome Measures

Primary Outcomes (1)

  • define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events

    from the beginning of anesthesia till 4 hours after the end of the surgery

Secondary Outcomes (3)

  • define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation

    from the beginning of anesthesia till 4 hours after the end of the surgery

  • define the correlation coefficient between systemic and/or cerebral desaturation phases and the length of stay in intensive care unit

    duration of intensive care stay, an expected average of 4 days

  • validate the equivalence of the systemic and cerebral oxymetry

    from the beginning of anesthesia till 4 hours after the end of the surgery

Interventions

systemic and cerebral oxymetryOTHER

oxymetry measurement using near infrared spectroscopy

Also known as: oxymetry measurement using near infrared spectroscopy

Eligibility Criteria

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

patient undergoing hepatic surgery or liver transplantation

You may qualify if:

  • patients undergoing an hepatic resection or hepatic transplantation
  • patients able to give consent with knowledge of french or english language.

You may not qualify if:

  • age\< 18 years
  • patients with cerebral diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3J4, Canada

Location

Study Officials

  • Franck Vandenbroucke-Menu, MD

    Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    PRINCIPAL INVESTIGATOR

  • Réal Lapointe, MD-FRCS

    Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    PRINCIPAL INVESTIGATOR

  • André Denault, MD PhD

    Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2011

First Posted

October 24, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

CA(1)