NCT02846818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

July 19, 2016

Last Update Submit

July 26, 2016

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Keywords

MicrodialysisCardiac surgeryLactate to pyruvate ratioCardiopulmonary bypassNeurological complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mini mental state examination (MMSE)

    Neurological complications with in 2 days after surgery

  • Near-infrared spectroscopy (NIRS)

    one day

Study Arms (2)

Low mean arterial perfusion pressure

EXPERIMENTAL

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

High mean arterial perfusion pressure

EXPERIMENTAL

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

Interventions

MicrodialysisPROCEDURE

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

Also known as: MMSE, NIRS
High mean arterial perfusion pressureLow mean arterial perfusion pressure

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective CABG on CPB

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (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.

    PMID: 14674968BACKGROUND

  • 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.

    PMID: 24703207BACKGROUND

MeSH Terms

Interventions

Microdialysis

Intervention Hierarchy (Ancestors)

DialysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Palle Toft, Professor

    Odense University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 27, 2016

Study Start

February 1, 2015

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

DK(1)