NCT01748266

Brief Summary

Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

December 7, 2012

Last Update Submit

December 11, 2012

Conditions

Elective Cardiac Surgery

Keywords

StO2microcirculationNIRS

Outcome Measures

Primary Outcomes (1)

  • microcirculatory reactivity

    Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence

    10 minutes before anesthésia induction

Secondary Outcomes (1)

  • microcirculatory reactivity

    during CPB (30 minutes after the start), and 2, 6, 12, 24 and 48 hours after the end of the CPB

Study Arms (1)

microcirculatory reactivity

Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.

Other: microcirculatory reactivity

Interventions

microcirculatory reactivityOTHER

Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.

microcirculatory reactivity

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB

You may qualify if:

  • Age \> 18 years
  • scheduled for an elective cardiac surgery at high risk of post operative systemic inflammatory response syndrome

You may not qualify if:

  • BMI\>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Study Officials

  • Jerome MOREL, Md

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 12, 2012

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

FR(1)