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Neuromonitoring in Patients During Aortic Valve Replacement (IMLPBIAVR)

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ClinicalTrials.gov Identifier: NCT02697786
Recruitment Status : Unknown
Verified October 2016 by Marija Bozhinovska, University Medical Centre Ljubljana.
Recruitment status was:  Enrolling by invitation
First Posted : March 3, 2016
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Marija Bozhinovska, University Medical Centre Ljubljana

Brief Summary:

Postoperative brain damage and neuropsychological disorders have been observed in 30 - 80 % of patients after heart surgery with the use of cardiopulmonary bypass (CPB).They can persist up to a year after cardiac surgery and are associated with increased hospital mortality and prolonged intrahospital stay.

Hypoperfusion,hyperthermia,atrial fibrillation,genetic predisposition and systemic inflammatory response associated with CPB have been identified as pathophysiological mechanisms.However, some authors consider cerebral embolisation to be the prevalent mechanism of intraoperative brain injury after cardiac surgery,as gaseous or solid cerebral emboli can cause ischemia, inflammation and edema,consequently causing cerebral infarctions usually resulting with stroke,coma,encephalopathy, delirium and cognitive decline. Additionally,they may impair cerebrovascular reactivity (CVR).

Aortic valve replacement (AVR) preformed by full sternotomy is the standard approach in the treatment of aortic valve disease. Minimally invasive (MIS) aortic valve replacement has been shown to reduce postoperative mortality, morbidity, and pain while providing faster recovery, a shorter hospital stay, and better cosmetic results. However, due to technically more demanding procedure, MIS may lead to prolonged CPB time and incomplete de-airing of the heart with an increased risk for cerebral gas embolization. Therefore, the choice of MIS might bear an augmented risk for brain injury.

Transcranial Doppler (TCD) enables real time detection of intraoperative emboli in the cerebral arteries seen as microembolic signals (MES), and is an essential neuromonitoring tool. Several studies demonstrated correlation between the number of MES and the occurrence as well as severity of postoperative neurological complications. However, the factors contributing to brain injury have not been elucidated in those studies. The investigators speculate that impairment of CVR is an important mechanism that persists and prolongs the duration of brain injury into postoperative period.

The aim of the study is to compare two surgical approaches used for AVR, with focus on the number of MES and their impact on levels of protein S100B (marker of brain tissue damage),postoperative CVR and cognitive function With the results,the investigators aim to help surgeons in selecting the appropriate technique for AVR in individual participants,as well as to clarify the effect of aortic valve surgery on the brain.


Condition or disease Intervention/treatment Phase
Brain Injury Device: Transcranial doppler Phase 3

Detailed Description:
Patients undergoing for aortic valve replacement will be enrolled in the study after giving the signed informed consent and will be divided in two groups depending on the type of the surgical technique. Either full sternotomy (FS) or minimal invasive sternotomy (MIS) will be performed, both with the use of cardio-pulmonary bypass (CPB).One week before and one week after the surgery patients will undergo mini mental test and measurement of visually evoked cerebral blood flow velocity response (VEFR).Levels of S100B, interleukin (IL) 1, IL 6, IL 8, IL 10 and microparticles will be determined before induction of anesthesia,as well as 6 h, 24 h, 48 h and 7 days after CPB.Each patient will have invasive and non invasive monitoring that will include near infrared spectroscopy (NIRS), bispectral index (BIS) and TCD during surgery.MES will be detected using TCD at the following time-points: beginning of surgery, after sternotomy, during aortic cannulation, during CPB, during de-airing, opening of the clamp on the aorta and after CBP removal before chest closure.All of this data will be documented as well as the demographic characteristics of patients, their preoperative medical status, and intraoperative data (duration of surgery, duration of CPB, hemodynamic parameters, inotropic/vasoactive support,blood and blood components); duration of mechanical ventilation in intensive care unit (ICU), duration of ICU stay, 30-day mortality and morbidity, as well as postoperative complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Intraoperative Microemboli Load on Postoperative Brain Injury in Patients Undergoing Aortic Valve Replacement Preformed With Two Different Surgical Approaches
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Active Comparator: AVR preformed with full sternotomy

30 patients, 7 days before and after surgery mini mental test and measurement of visual evoked cerebral blood flow response (VEFR) will be done.

Transcranial doppler measurements 1. beginning of the surgery, 2.after sternotomy, 3.during aortic cannulation,4.during CPB,5. during de-airing, 6. opening of the clamp on the aorta, 7. after CPB removal before chest closure. Prolonged de airing if needed

Device: Transcranial doppler
Prolonged de airing to decrease the number of MES

Experimental: AVR preformed with minimal invasive sternotomy

30 patients, 7 days before and after surgery mini mental test and measurement of visual evoked cerebral blood flow response (VEFR) will be done.

Transcranial doppler measurements 1. beginning of the surgery, 2.after sternotomy, 3.during aortic cannulation,4.during CPB,5. during de-airing, 6. opening of the clamp on the aorta, 7. after CPB removal before chest closure. Prolonged de airing if needed

Device: Transcranial doppler
Prolonged de airing to decrease the number of MES




Primary Outcome Measures :
  1. Detection of the intraoperative microembolic signals during minimal invasive sternotomy compared to full sternotomy with TCD during aortic valve surgery [ Time Frame: Intraoperative detection:Beginning of surgery, after sternotomy, during aortic cannulation, during CPB, during de-aeration, opening of the clamp on the aorta and after CBP removal before chest closure. ]
  2. Detection of S100B serum protein, marker of brain tissue damage [ Time Frame: Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB ]
  3. Detection of serum interleukin IL-1, IL-6,IL-8,Il-10 and Microparticles [ Time Frame: Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB ]

Secondary Outcome Measures :
  1. Assessment of cerebrovascular reactivity using visually evoked cerebral blood flow velocity response (VEFR) measurements [ Time Frame: 7 days before and 7 days after surgery ]
  2. Assessment of neurologic and cognitive function in patients undergoing AVR [ Time Frame: 7 days before and 7 days after surgery ]

Other Outcome Measures:
  1. Length of ICU stay [ Time Frame: Post operative period, an expected average of 2 days ]
  2. Requirement for inotropic and vasoactive therapy [ Time Frame: 1)After induction of anesthesia, 2)at the end of CPB ,3) postoperative period ]
  3. Duration of mechanical ventilation [ Time Frame: postoperative period, an expected average 2 days ]
  4. 30 days mortality [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Isolated aortic valve stenosis as well as asymptomatic patients with depressed systolic function
  • Symptomatic patients with normal or depressed left ventricular function
  • Patients with American Society of Anesthesiologist (ASA) physical status classification 2 or 3

Exclusion Criteria:

  • History of brain stroke
  • EF less than 20%
  • History of alcohol abuse
  • Epilepsy of history of psychiatric illness and antipsychotic drugs
  • Patients with stenosis on carotid arteries
  • Patients with preformed surgery or already stented carotid arteries
  • Patients with poor or absent acoustic temporal window
  • Diagnosed dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697786


Locations
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Slovenia
University Clinical center
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Marija Bozhinovska
Slovenian Research Agency
Investigators
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Study Director: Maja Sostaric, MD, PhD University Medical Centre Ljubljana
Study Director: Matej Podbregar, MD, PhD University Medical Centre Ljubljana
Study Director: Tomislav Klokocovnik, MD,PhD University Medical Centre Ljubljana
Study Director: Borut Gersak, MD, PhD University Medical Centre Ljubljana
Principal Investigator: Marija Bozhinovska, MD, MSc University Medical Centre Ljubljana

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Responsible Party: Marija Bozhinovska, MD, MSc, Spec., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02697786     History of Changes
Other Study ID Numbers: ARRS-RPROJ - J R- 2014- 191
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marija Bozhinovska, University Medical Centre Ljubljana:
Aortic valve surgery
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System