A New Non-invasive Marker to Detect Silent Hypoxia in Patients Undergoing Cardiac Surgery

NCT ID: NCT01560611

Last Updated: 2012-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgical Procedures High-risk Surgical Patient Anaerobic Threshold

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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High-risk cardiac surgery patient

Near infrared spectroscopy

Intervention Type DEVICE

Interventions

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Near infrared spectroscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Emergency situation
* Patient on ECMO
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien POTTECHER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

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Pôle d'anesthésie réanimation - Nouvel Hôpital Civil

Strasbourg, , France

Site Status

Countries

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France

Central Contacts

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Julien POTTECHER, MD

Role: CONTACT

33.3.88.12.70.95

Facility Contacts

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Julien POTTECHER, MD

Role: primary

33.3.88.12.70.95

Other Identifiers

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5162

Identifier Type: -

Identifier Source: org_study_id

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