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Completed

NCT Number: NCT02846818

Cerebral Energy State in Cardiac Surgery

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.

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Key information

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, Fyn, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Microdialysis

Procedure

Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein.

Other names: MMSE, NIRS

Primary outcomes

  1. Extracerebral microdialysis parameters

    Time frame: 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 outcomes

  1. Mini mental state examination (MMSE)

    Time frame: Neurological complications with in 2 days after surgery

    Patients were assessed preoperatively and postoperatively day two after surgery

  2. Near-infrared spectroscopy (NIRS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2016
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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