Cerebral Energy State in Cardiac Surgery

Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846818
• Other study ID #: S-20130166
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: July 26, 2016
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Postoperative; Dysfunction Following Cardiac Surgery

Intervention

Procedure:
• Microdialysis
Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Ahonen J, Salmenperä M. Brain injury after adult cardiac surgery. Acta Anaesthesiol Scand. 2004 Jan;48(1):4-19. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mini mental state examination (MMSE)	Patients were assessed preoperatively and postoperatively day two after surgery	Neurological complications with in 2 days after surgery	No
Secondary	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	No