NCT01560611

Brief Summary

In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

First QC Date

March 20, 2012

Last Update Submit

March 21, 2012

Conditions

Cardiac Surgical ProceduresHigh-risk Surgical PatientAnaerobic Threshold

Study Arms (1)

High-risk cardiac surgery patient

Device: Near infrared spectroscopy

Interventions

Near infrared spectroscopyDEVICE
High-risk cardiac surgery patient

Eligibility Criteria

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

Patients undergoing cardiac surgical procedures under cardiopulmonary bypass in Strasbourg University Hospital

You may qualify if:

  • Age \> 18 yo
  • Cardiac surgical procedure under cardiopulmonary bypass
  • High-risk surgical patient fulfilling one of the following items:
  • Euroscore \>= 6
  • Ejection fraction \< 40%
  • Creatinine clearance \< 40mL/min
  • Pulmonary arterial pressure \> 45mmHg
  • Signed informed consent
  • Social security affiliation

You may not qualify if:

  • Emergency situation
  • Patient on ECMO
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle d'anesthésie réanimation - Nouvel Hôpital Civil

Strasbourg, France

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Julien POTTECHER, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien POTTECHER, MD

CONTACT

33.3.88.12.70.95julien.pottecher@chru-strasbourg.fr

Study Design

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

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

March 1, 2012

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

FR(1)