Cerebral Energy State in Cardiac Surgery

Continuous Monitoring of Cerebral Energy State During Cardiac Surgery - A Novel Approach Utilizing Intravenous Microdialysis

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.

Study Overview

• Status: Completed
• Conditions: Postoperative; Dysfunction Following Cardiac Surgery
• Intervention / Treatment: Procedure: Microdialysis

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Fyn
    • Odense, Fyn, Denmark, 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Elective CABG on CPB

Exclusion criteria:

• Acute patients or reoperations
• Patients with epidural catheter
• Previous stroke
• Stenotic carotids
• Ejection fraction (EF) < 50 %
• Estimated per operative risk > 5%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low mean arterial perfusion pressure; 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.	Procedure: Microdialysis; Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein.; Other Names: MMSE; NIRS
Experimental: High mean arterial perfusion pressure; 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.	Procedure: Microdialysis; Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein.; Other Names: MMSE; NIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extracerebral microdialysis parameters	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.	MD parameters were measured intraoperatively and for two hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini mental state examination (MMSE)	Patients were assessed preoperatively and postoperatively day two after surgery	Neurological complications with in 2 days after surgery
Near-infrared spectroscopy (NIRS)	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	one day

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Director: Palle Toft, Professor, Odense University Hospital

Publications and helpful links

General Publications

• McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.
• Ahonen J, Salmenpera M. Brain injury after adult cardiac surgery. Acta Anaesthesiol Scand. 2004 Jan;48(1):4-19. doi: 10.1111/j.1399-6576.2004.00275.x.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Microdialysis; Cardiac surgery; Cardiopulmonary bypass; Neurological complications; Lactate to pyruvate ratio
• Other Study ID Numbers: S-20130166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided