- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01319799
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve
Study Overview
Detailed Description
Patients and clinical procedures 10 patients scheduled for open aortic valve surgery at our institution will be included into this prospective, observational study. The Human Ethics Committee of the University of Gothenburg, approved the study protocol. The day before surgery a lumbar puncture at level L3-4 will be performed using a 27G Whitacre needle. A sample of 2.5 ml of cerebrospinal fluid will be taken for analysis of S-100B, NSE, Tau and albumin.
On arrival at OR, standard perioperative monitoring will be established, including an Auditory Evoked Potential (AEP) monitor for anaesthetic depth measurements (AEP Monitor/2, Danmeter, Odense, Denmark) and radial arterial and central venous lines. General anaesthesia is induced with propofol 0.5-1 mg/kg and fentanyl 10 μg/kg. Tracheal intubation will be facilitated using atracurium 0,5 mg/kg. Sevoflurane is used to maintain an anaesthetic depth adjusted to an AAI index of 15-30 as recorded by the AEP monitor. Hemodynamic stability will be obtained by the use of colloidal solution administration, guided by the use of intra-operative transesophageal echocardiography, and norephineprine to maintain a mean arterial pressure above 75 mmHg-Also during CPB. A lumbar puncture will be repeated the first postoperative day repeating the measurement of markers in CSF A certified cardiologist or anaesthesiologist assess focal neurological impairment before and within 24 hours after the procedure.
Transcranial Doppler (TCD) By TCD the right medial cerebral artery (RMCA) will be insonated by the transtemporal approach at a depth of approximately 50 mm using standard criteria. The investigators use a 2 MHz power M-mode TCD monitor (ST3 ©, Spencer Technologies Seattle, WA), with the probe fixed in position using a head frame. The Doppler signals will be continuously monitored and saved to monitor hard drive. Two physicians independently evaluate the TCD data files offline, and identify microembolic signals (MES) using criteria for counting emboli signals on spectral and PMD TCD.
Statistical Analysis: Descriptive statistics and tests of normality for continuos data Correlation analysis; Total cerebral embolic load vs. increase of CSF level S-100B/ NSE/Tau.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gothenburg, Sweden, 41345
- Department of Thoracic Anaesthesia & Intensive Care,Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis aortic stenosis eligible for surgical treatment
Exclusion Criteria:
- Coagulopathy
- Regular Anticoagulation therapy
- Carotid stenosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Surgical aortic valve replacement
Single observational study.
Count of microembolic signals during open heart surgery and measurement of properative vs postoperative levels of markers in cerebrospinal fluid of neuronal damge.
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TCD count of microembolic signals during surgical aortic valve replacement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery
Time Frame: (day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance
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Transcranial Doppler measurement of microembolic signals will be measured during the surgical procedure.Microembolic signals are detected by offline analysis of the Dopplerspectral analysis of the blood flow in the medial cerebral artery.
Different intensities (dB),flow direction and time frame appearances in the Doppler spectral envelope is distinguishable for a neurosonolgist according to predefined criteria for an embolic signal-defined in previous litterature.The total amount of signals during one surgical procedure is counted.
The appearance of microembolic signals related to specific procedures performed during cardiac surgery with cardiopulmonary bypass is noted.
The exact time range is not possible to estimate in advance,due to the fact that each surgical procedure varies in time.The range of values for each individual patient, based on pilos, will vary from 50 to approximately 1500 embolic counts for one surgical procedure.
A high value is negative for the patient.
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(day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebrospinal Fluid(CSF) Levels of S-100B(Microgram/Liter)
Time Frame: 24 Hours after Surgery
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Differences in preoperative vs postoperative CSF levels of S-100B in microgram/Liter The assumption is that a cardiac open heart surgical procedure with cardiopulmonary bypass will influence the postoperative level of marker of neuronal cell damage in the central nerve system. An increase in the levels, compared to the preoperative values, indicates neuronal cell damage detectable in the CSF, namely the brains own extracellular fluid. |
24 Hours after Surgery
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Collaborators and Investigators
Investigators
- Study Director: Sven Erik Ricksten, Professor, Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care
Publications and helpful links
General Publications
- Stolz E, Gerriets T, Kluge A, Klovekorn WP, Kaps M, Bachmann G. Diffusion-weighted magnetic resonance imaging and neurobiochemical markers after aortic valve replacement: implications for future neuroprotective trials? Stroke. 2004 Apr;35(4):888-92. doi: 10.1161/01.STR.0000120306.82787.5A. Epub 2004 Feb 19.
- Abu-Omar Y, Balacumaraswami L, Pigott DW, Matthews PM, Taggart DP. Solid and gaseous cerebral microembolization during off-pump, on-pump, and open cardiac surgery procedures. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1759-65. doi: 10.1016/j.jtcvs.2003.09.048.
- Kruis RW, Vlasveld FA, Van Dijk D. The (un)importance of cerebral microemboli. Semin Cardiothorac Vasc Anesth. 2010 Jun;14(2):111-8. doi: 10.1177/1089253210370903.
- van Dijk D, Kalkman CJ. Why are cerebral microemboli not associated with cognitive decline? Anesth Analg. 2009 Oct;109(4):1006-8. doi: 10.1213/ANE.0b013e3181b5af06. No abstract available.
- Martin KK, Wigginton JB, Babikian VL, Pochay VE, Crittenden MD, Rudolph JL. Intraoperative cerebral high-intensity transient signals and postoperative cognitive function: a systematic review. Am J Surg. 2009 Jan;197(1):55-63. doi: 10.1016/j.amjsurg.2007.12.060. Epub 2008 Aug 23.
- Anderson RE, Hansson LO, Nilsson O, Liska J, Settergren G, Vaage J. Increase in serum S100A1-B and S100BB during cardiac surgery arises from extracerebral sources. Ann Thorac Surg. 2001 May;71(5):1512-7. doi: 10.1016/s0003-4975(01)02399-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr112-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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