Postoperative; Dysfunction Following Cardiac SurgeryNCT02846818
Cerebral Energy State in Cardiac Surgery
A study testing Microdialysis in people with Postoperative; Dysfunction Following Cardiac Surgery, run by Odense University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative; Dysfunction Following Cardiac Surgery
- What is being tested?
- Microdialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective CABG on CPB
Who cannot join
- Acute patients or reoperations
- Patients with epidural catheter
- Previous stroke
- Stenotic carotids
- Ejection fraction (EF) < 50 %
- Estimated per operative risk > 5%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Microdialysis
- Keywords
- Microdialysis, Cardiac surgery, Lactate to pyruvate ratio, Cardiopulmonary bypass, Neurological complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodialysisProcedure or surgery
Also called MMSE, NIRS
Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Microdialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MD parameters were measured intraoperatively and for two hours postoperatively
Secondary outcomes (2)
Mini mental state examination (MMSE)
Patients were assessed preoperatively and postoperatively day two after surgery
Measured: 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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative; Dysfunction Following Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Mölström, Odense University Hospital
- Investigators
- Palle Toft, Professor, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846818
- Sponsor's protocol ID
- S-20130166
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 14674968McDonagh 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.
PubMed 24703207
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Cerebral Energy State During Cardiac Surgery - A Novel Approach Utilizing Intravenous Microdialysis
- ClinicalTrials.gov ID
- NCT02846818
- Acronym / sponsor ID
- S-20130166
- Keywords
- Microdialysis, Cardiac surgery, Lactate to pyruvate ratio, Cardiopulmonary bypass, Neurological complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low mean arterial perfusion pressure | Experimental | Procedure: Microdialysis5 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. |
| High mean arterial perfusion pressure | Experimental | Procedure: Microdialysis5 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective CABG on CPB
Key exclusion criteria (6 listed)
- Acute patients or reoperations
- Patients with epidural catheter
- Previous stroke
- Stenotic carotids
- Ejection fraction (EF) < 50 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrodialysisAlso: MMSE, NIRSExtracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein. | Procedure or surgery | High mean arterial perfusion pressure, Low mean arterial perfusion pressure |
Primary outcome
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.
2 secondary outcomes
Mini mental state examination (MMSE)
Time frame: Neurological complications with in 2 days after surgery
Near-infrared spectroscopy (NIRS)
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Background: PubMed 14674968Ahonen 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.
- Background: PubMed 24703207McDonagh 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Palle Toft, Professor study director
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdialysis in people with Postoperative; Dysfunction Following Cardiac Surgery, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracerebral microdialysis parameters (time frame: MD parameters were measured intraoperatively and for two hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846818, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.