Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Correction rSO2 desaturation.
Standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring Cerebral near-infrared spectroscopy monitoring, Postoperative complications, Cardiac surgery
Eligibility Criteria
Inclusion Criteria:
High-risk cardiac surgery patients as determined by at least one of the followings:
- the age greater than or equal to 75 years on the day of screening;
- left ventricle ejection fraction less than 35%;
- use of a preoperative intraaortic balloon pump;
- combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance < 60 ml/min)
Exclusion Criteria:
- refusal of consent
Sites / Locations
- Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C. Predefined protocol of interventions for correcting rSO2 desaturation (< 60%) during cardiac surgery and the first six hours after it.
Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it.
Outcomes
Primary Outcome Measures
Incidence of postoperative complications
This composite outcome includes: myocardial infarction, stroke, delirium, postoperative cognitive dysfunction, wound infection, mediastinitis, mechanical ventilation more than 24 h, arrhythmia, reoperation for bleeding, acute kidney injury, and acute kidney injury requiring dialysis.
Secondary Outcome Measures
Incidence of major organ morbidity and mortality
This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death
Duration of intensive care unit stay
Duration of postoperative hospital stay
Death from all causes at 30 days
Full Information
NCT ID
NCT02155868
First Posted
May 31, 2014
Last Updated
January 25, 2017
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT02155868
Brief Title
Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery
Official Title
Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.
Hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Cerebral near-infrared spectroscopy monitoring, Postoperative complications, Cardiac surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C.
Predefined protocol of interventions for correcting rSO2 desaturation (< 60%) during cardiac surgery and the first six hours after it.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it.
Intervention Type
Other
Intervention Name(s)
Correction rSO2 desaturation.
Intervention Description
Predefined protocol of interventions for correcting rSO2 desaturation (< 60%) during cardiac surgery and the first six hours after it.
In case of rSO2 decrease less than 60% correct:
head position; position of aortic,venous cannulae and central venous catheters; partial pressure of carbon dioxide in arterial blood < 35 mmHg; mean arterial pressure < 60 mmHg; central venous pressure > 10 mmHg; cardiac index < 2.0 l/min/m2; mixed venous oxygen saturation < 60%; hemoglobin < 65 g/L during cardiopulmonary bypass or hemoglobin < 90 g/L after cardiopulmonary bypass; decrease cerebral O2 consumption.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Intervention Description
Standard treatment
Primary Outcome Measure Information:
Title
Incidence of postoperative complications
Description
This composite outcome includes: myocardial infarction, stroke, delirium, postoperative cognitive dysfunction, wound infection, mediastinitis, mechanical ventilation more than 24 h, arrhythmia, reoperation for bleeding, acute kidney injury, and acute kidney injury requiring dialysis.
Time Frame
Up to 30 day after randomisation
Secondary Outcome Measure Information:
Title
Incidence of major organ morbidity and mortality
Description
This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death
Time Frame
Up to 30 day after randomization
Title
Duration of intensive care unit stay
Time Frame
Up to 30 day after randomization
Title
Duration of postoperative hospital stay
Time Frame
Up to 30 day after randomization
Title
Death from all causes at 30 days
Time Frame
Up to 30 day after randomisation
Other Pre-specified Outcome Measures:
Title
Incidence of desaturation episodes
Description
Desaturation is defined as level of rSO2 less than 60%.
Time Frame
Intra operative
Title
Severity of desaturation episodes
Description
Severity is defined as the product of length of time and depth of rSO2 less than 60%
Time Frame
Intra operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High-risk cardiac surgery patients as determined by at least one of the followings:
the age greater than or equal to 75 years on the day of screening;
left ventricle ejection fraction less than 35%;
use of a preoperative intraaortic balloon pump;
combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance < 60 ml/min)
Exclusion Criteria:
refusal of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir V Lomivorotov, Prof
Organizational Affiliation
Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
City
Novosibirsk
State/Province
Novosibirsk Territory
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
17179242
Citation
Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
Results Reference
background
PubMed Identifier
15578464
Citation
Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007.
Results Reference
background
PubMed Identifier
19101265
Citation
Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
Results Reference
background
PubMed Identifier
20579669
Citation
Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.
Results Reference
background
PubMed Identifier
21178669
Citation
Heringlake M, Garbers C, Kabler JH, Anderson I, Heinze H, Schon J, Berger KU, Dibbelt L, Sievers HH, Hanke T. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011 Jan;114(1):58-69. doi: 10.1097/ALN.0b013e3181fef34e.
Results Reference
background
PubMed Identifier
18270192
Citation
Denault A, Deschamps A, Murkin JM. A proposed algorithm for the intraoperative use of cerebral near-infrared spectroscopy. Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):274-81. doi: 10.1177/1089253207311685.
Results Reference
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Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery
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