The Effect of Nitroglycerin Infusion Rate on Cerebral Rewarming During Hypothermic Coronary Artery Bypass Grafting
NCT ID: NCT03251599
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
78 participants
INTERVENTIONAL
2017-08-16
2017-11-22
Brief Summary
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To overcome this constriction of the vessels, and decrease the workload of the heart, glyceryl trinitrate is infused. This drug causes significant dilatation in arteries and veins, which allows the heart to pump the blood with less force. The dilatation of the vessels also allows the body to rewarm more easily.
The investigators' concern is whether increased infusion rates of glyceryl trinitrate may cause uncontrolled rewarming of the brain or not. The investigators will measure the temperature of the brain using a temperature probe located in the nasal cavity. The temperature will be recorded at each minute during the the rewarming period. Results of two commonly used infusion rates of glyceryl trinitrate will be compared.
Detailed Description
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Although hypothermia is effectively used to protect the brain and myocardium from ischemia, studies report that rapid rewarming is correlated with brain injury. Therefore it is common practice to monitor the nasopharyngeal temperature and to keep the gradient between heat-exchanger and nasopharynx during rewarming at 2-3 °C.
This study's main concern is that the infusion rate of glyceryl trinitrate may affect the rewarming rate of the body and the brain during te rewarming period. One possibility is that the increased vasodilatation resulting from glyceryl trinitrate may divert most of the heat to the body and protect the brain from overheating. The other possibility is that the increased partial pressures of carbon dioxide may render the brain more susceptible to the vasodilatatory actions of glyceryl trinitrate, which may cause the brain to overheat.
This study will measure temperatures at several sites of the patient and the cardiopulmonary bypass machine:
* Nasopharynx: a probe inside the nasal cavity, located above the palate.
* Core temperature: a probe inside the esophagus, 12 cm distal from where the heart and breath sounds are heard best.
* Heat-exchanger: recorded as is supplied by the heat exchanger as the temperature of the water inside the heat exchanger.
* Returning blood: measured at the entrance of reservoir
* Blood leaving the oxygenator: measured at the outlet of the oxygenator
All patients scheduled for cardiopulmonary bypass grafting surgery, and aortic arch surgery will be recruited.
Data will be collected by an observer blinded to the glyceryl trinitrate dose used. Data management will be done via an electronic database including demographic data, anesthetic records, and bypass records of the patient. All data will be anonymized on a case-by-case fashion after the surgery. Data analysis will be performed using R statistical software.
Any adverse events, including adverse drug reactions, and adverse patient outcomes associated with monitoring tools and patient management will be reported to the Ethics Committee. Should any change to the research protocol required, the Ethics Committee will be informed.
Sample size for each sample is calculated (according to the primary outcomes of the study) as 48 to detect a 20 % difference in time to reach optimal body temperature (expected mean 30 ± 5 minutes, or a 0.3 °C difference in nasopharyngeal temperature when the esophageal temperature reached 37 °C.
In case of missing data (such as due to equipment malfunction, inability to monitor the patient, data not reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results), the participant will be excluded from the study.
The statistical analysis will include descriptive statistics of patient demographics, comparison of both primary outcomes, and comparisons of adverse events.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
The perfusionist, who is the main care provider during the rewarming period of the cardiopulmonary bypass, will be blinded to the dose of the study drug.
The investigator will be blinded, and will be responsible from the collection, and validation of the data.
Study Groups
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Glyceryl trinitrate 0.2
Drug Intervention Generic name: Glyceryl trinitrate Dosage form: Ampoule for intravenous infusion Dosage: 0.2 mcg/kg/minute Frequency and duration: The infusion will start as soon as the rewarming period starts, will continue throughout the operation and throughout the first 24 hours of the postoperative period.
Glyceryl trinitrate 0.2
These patients will receive glyceryl trinitrate infusion at a rate of 0.2 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
Glyceryl trinitrate 0.5
Drug Intervention Generic name: Glyceryl trinitrate Dosage form: Ampoule for intravenous infusion Dosage: 0.5 mcg/kg/minute Frequency and duration: The infusion will start as soon as the rewarming period starts, will continue throughout the operation and throughout the first 24 hours of the postoperative period.
Glyceryl trinitrate 0.5
These patients will receive glyceryl trinitrate infusion at a rate of 0.5 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
Interventions
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Glyceryl trinitrate 0.2
These patients will receive glyceryl trinitrate infusion at a rate of 0.2 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
Glyceryl trinitrate 0.5
These patients will receive glyceryl trinitrate infusion at a rate of 0.5 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Recep Tayyip Erdogan University
OTHER
Responsible Party
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Başar Erdivanlı
Asst. Prof. of Anesthesiology and Reanimation
Principal Investigators
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Başar Erdivanlı, M.D.
Role: PRINCIPAL_INVESTIGATOR
Recep Tayyip Erdogan University Medical Faculty
Locations
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Recep Tayyip Erdogan University, Medical Faculty
Rize, , Turkey (Türkiye)
Countries
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References
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Johansson BW. The hibernator heart--nature's model of resistance to ventricular fibrillation. Cardiovasc Res. 1996 May;31(5):826-32. doi: 10.1016/0008-6363(95)00192-1.
Michenfelder JD, Milde JH. The relationship among canine brain temperature, metabolism, and function during hypothermia. Anesthesiology. 1991 Jul;75(1):130-6. doi: 10.1097/00000542-199107000-00021.
Hori D, Everett AD, Lee JK, Ono M, Brown CH, Shah AS, Mandal K, Price JE, Lester LC, Hogue CW. Rewarming Rate During Cardiopulmonary Bypass Is Associated With Release of Glial Fibrillary Acidic Protein. Ann Thorac Surg. 2015 Oct;100(4):1353-8. doi: 10.1016/j.athoracsur.2015.04.006. Epub 2015 Jul 7.
Engelman R, Hammon JW, Baker RA, Shore-Lesserson L. Rapid Rewarming During Cardiopulmonary Bypass Is Associated With Cerebral Injury. Ann Thorac Surg. 2016 May;101(5):2026-7. doi: 10.1016/j.athoracsur.2015.11.021. No abstract available.
Grigore AM, Grocott HP, Mathew JP, Phillips-Bute B, Stanley TO, Butler A, Landolfo KP, Reves JG, Blumenthal JA, Newman MF; Neurologic Outcome Research Group of the Duke Heart Center. The rewarming rate and increased peak temperature alter neurocognitive outcome after cardiac surgery. Anesth Analg. 2002 Jan;94(1):4-10, table of contents. doi: 10.1097/00000539-200201000-00002.
Other Identifiers
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2017/5
Identifier Type: -
Identifier Source: org_study_id