Cerebral Energy State in Cardiac Surgery

Not Applicable

Completed

• Conditions: Postoperative; Dysfunction Following Cardiac Surgery
• Interventions: Procedure: Microdialysis

• Registration Number: NCT02846818
• Lead Sponsor: Odense University Hospital

Brief Summary

Impaired cerebral function remains an important complication of cardiopulmonary bypass (CPB) during cardiac surgery. The aim of the present study is to investigate whether the lactate to pyruvate (LP) ratio obtained by microdialysis (MD) of the cerebral venous outflow reflects a derangement of global cerebral energy state during cardiopulmonary bypass.

Detailed Description

Patients undergoing primary, elective coronary artery bypass grafting were blindly randomized to usual range MAP (40 to 60 mmHg; n = 5) or intervention group MAP (60 to 80 mmHg; n = 5) during CPB. MD catheters were positioned in a retrograde direction in the internal jugular vein and a reference catheter was inserted into the brachial artery. The relations between LP ratio, MAP, data obtained from bi-frontal NIRS and neurological outcome measures were assessed.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low mean arterial perfusion pressure	Microdialysis	5 patients undergoing primary, elective coronary artery bypass grafting were randomized to usual range MAP (40 to 60 mmHg) during CPB. Microdialysis catheters were positioned in a retrograde direction in the internal jugular vein.
High mean arterial perfusion pressure	Microdialysis	5 patients undergoing primary, elective coronary artery bypass grafting were blindly randomized to intervention group MAP (60 to 80 mmHg) during CPB. Microdialysis catheters were positioned in a retrograde direction in the internal jugular vein.

Primary Outcome Measures

Name	Time	Method
Extracerebral microdialysis parameters	MD parameters were measured intraoperatively and for two hours postoperatively	Does the LP ratio of cerebral venous blood increase significantly during CPB indicating compromised cerebral oxidative metabolism.The analyses included the variables routinely monitored during intracerebral microdialysis: glucose, pyruvate, lactate, glutamate, glycerol and lactate to pyruvate ratio.

Secondary Outcome Measures

Name	Time	Method
Mini mental state examination (MMSE)	Neurological complications with in 2 days after surgery	Patients were assessed preoperatively and postoperatively day two after surgery
Near-infrared spectroscopy (NIRS)	one day	Right and left frontal rSO2 values were recorded simultaneously pre- and intraoperatively and for two hours postoperatively. Cerebral desaturation was defined as a decrease in the relative rSO2 value of 20 % compared with the individual pre-induction baseline value

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Fyn, Denmark