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NCT01560611 Clinical Trial

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

Cardiac Surgical Procedures Clinical Trial

Official title:
The Somatic-to-cerebral Oxygen Saturation Gradient as a Non-invasive Index of Anaerobic Threshold in High-risk Cardiac Surgical Patient

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01560611
Other study ID # 5162
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 20, 2012
Last updated March 21, 2012
Start date March 2012

Study information
Verified date March 2012
Source University Hospital, Strasbourg, France
Contact Julien POTTECHER, MD
Phone 33.3.88.12.70.95
Email julien.pottecher@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Near infrared spectroscopy

Locations
Country Name City State
France Pôle d'anesthésie réanimation - Nouvel Hôpital Civil Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

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