Cerebral Energy State in Cardiac Surgery

NCT ID: NCT02846818

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Postoperative; Dysfunction Following Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Microdialysis

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Microdialysis

Intervention Type PROCEDURE

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

Interventions

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Microdialysis

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

Intervention Type PROCEDURE

Other Intervention Names

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MMSE NIRS

Eligibility Criteria

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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%
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Simon Mölström

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Palle Toft, Professor

Role: STUDY_DIRECTOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, Fyn, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 14674968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24703207 (View on PubMed)

Other Identifiers

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S-20130166

Identifier Type: -

Identifier Source: org_study_id

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