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Evaluation of cerebral circulation and metabolic properties in patients undergoing normothermic cardiopulmonary bypass with acute normovolemic hemodilution.

Evaluation of cerebral circulation and metabolic properties in patients undergoing normothermic cardiopulmonary bypass with acute normovolemic hemodilution.

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON28354
Enrollment
40
Registered
2009-03-12
Start date
2009-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiopulmonary bypass, hemodiltion, cerebral autoregulation, micro embolic signals.

Interventions

None listed

Sponsors

Jos Maessen, MD, PhD Maastricht University Medical Center, Dept. CTC Phone: +31-43-3877070
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Elective adult candidates for CABG surgery using CPB; 2. Male gender; 3. Age: 50 -70 years old; 4. Presence of a trans-temporal bone window; 5. Informed written consent obtained by the patient.

Exclusion criteria

Exclusion criteria: 1. Patients suffering from neurological disorders (e.g. cerebrovascular accident); 2. Patients suffering from renal diseases (e.g. renal failure, defined as laboratory tests indicating values of 2 or more times the normal values [urea >= 50 U/L, kreatinine >= 170 micromol/L]); 3. Patients suffering from liver diseases, defined as laboratory tests indicating values of 2 or more times the normal values (ASAT >= 50 U/L, ALAT >= 60 U/L, LD >= 600 U/L and gamma-GT >= 90 U/L); 4. Patients suffering from severe pulmonary disorders (e.g. chronic obstructive pulmonary disease, emphysema); 5. Insulin / non insulin dependent diabetics; 6. Hypothermia during CPB; 7. Severe atherosclerosis of the carotid or the middle cerebral artery; 8. Participation in an investigational drug trial within the preceding 30 days.

Design outcomes

Primary

MeasureTime frame
To evaluate the effects of normovolemic hemodilution levels during CPB on the dynamic cerebral autoregulation and cerebrovascular reactivity.

Secondary

MeasureTime frame
1. To evaluate the dynamic cerebral autoregulation with transcranial Doppler velocity and near infrared spectroscopy at different PaCO2 levels during normothermic CPB; 2. To evaluate the relation between PaCO2 values and the amount of micro emboli signals during CPB.

Contacts

Public ContactWerner Mess
werner.mess@mumc.nl+31-(0)43-3875268

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)