Coronary Artery BypassPhase 4nitrothermNCT03251599
The Effect of Nitroglycerin Infusion Rate on Cerebral Rewarming During Hypothermic Coronary Artery Bypass Grafting
A Phase 4 study testing Glyceryl trinitrate 0.2 and Glyceryl trinitrate 0.5 in people with Coronary Artery Bypass and Cardiopulmonary Bypass, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Glyceryl trinitrate is used in coronary artery bypass grafting surgery. This surgery frequently employs hypothermic cardiopulmonary bypass, where the whole body is cooled down to 28-32 °C to arrest the heart, and protect the organs from ischemic insult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass, Cardiopulmonary Bypass
- What is being tested?
- Glyceryl trinitrate 0.2 and Glyceryl trinitrate 0.5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2017to 22 Nov 2017
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are scheduled for on-pump coronary artery bypass grafting surgery
Who cannot join
- Administration of vasopressors during rewarming period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University, Medical Faculty
Rize, 53100
About this study
Official title: The Effect of Two Different Rates of Nitroglycerin Infusion on Cerebral Rewarming During Rewarming Period of Hypothermic Cardiopulmonary Bypass
Glyceryl trinitrate is used in coronary artery bypass grafting surgery. This surgery frequently employs hypothermic cardiopulmonary bypass, where the whole body is cooled down to 28-32 °C to arrest the heart, and protect the organs from ischemic insult. When the cardiac repair or grafting is done, the body is warmed to 37 °C. During this "rewarming period", the heart has to beat against the vessels, all of which are constricted due to hypothermia.
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.
Read the detailed description
Hypothermia had demonstrated potential benefits in myocardial infarction, organ transplantation, and cardiopulmonary bypass. The brain uses 2/3 of the oxygen it receives to support cerebral electrophysiological function, while the rest is used for maintenance of cellular integrity. Anesthetic drugs alter only the first portion, while temperature is the only agent known to affect both portions (the cerebral consumption of oxygen decreases 6-7 % per degree centigrade reduction in temperature).
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
- Coronary Artery Bypass, Cardiopulmonary Bypass
- Being tested
- Glyceryl trinitrate 0.2, Glyceryl trinitrate 0.5
- Keywords
- peak temperature, rewarming rate, surgical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl trinitrate 0.2Drug
Also called Nitroglycerin, Perlinganit
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 0.5Drug
Also called Nitroglycerin, Perlinganit
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.
| Study group | Role | What they receive |
|---|---|---|
| Glyceryl trinitrate 0.2 | Sham comparator | 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. Receives: Drug: Glyceryl trinitrate 0.2 |
| Glyceryl trinitrate 0.5 | Active comparator | 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. Receives: Drug: Glyceryl trinitrate 0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasopharyngeal temperature > 37 °C
If the nasopharyngeal temperature is > 37 °C by the time the esophageal temperature reached 37 °C.
Measured: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
Time to 37 °C
Time required to reach an esophageal temperature of 37 °C.
Measured: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
Secondary outcomes (7)
Adverse event: Regional cerebral oxygen saturation
Occurrence and degree of significant drop in regional cerebral oxygen saturation
Measured: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
Length of Intensive Care Unit stay
Outcome criteria for coronary artery bypass surgery: length of intensive care unit stay
Measured: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from Intensive Care Unit, whichever came first, assessed up to 1 month
Length of hospital stay
Outcome criteria for coronary artery bypass surgery: length of intensive care unit stay
Measured: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of atrial fibrillation
Outcome criteria for coronary artery bypass surgery: occurrence of atrial fibrillation
Measured: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of low cardiac output syndrome
Outcome criteria for coronary artery bypass surgery: occurrence of low cardiac output syndrome
Measured: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of stroke
Outcome criteria for coronary artery bypass surgery: occurrence of stroke
Measured: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of delirium
Outcome criteria for coronary artery bypass surgery: occurrence of postoperative delirium
Measured: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start16 Aug 2017
- Primary completion22 Nov 2017
- Study completion22 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention type is drug dosage. Patients will be assigned to 2 arms, where they will receive different doses of the same drug. The study will end when both of the arms will have at least 48 patients each.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başar Erdivanlı, Recep Tayyip Erdogan University
- Investigators
- Başar Erdivanlı, M.D., Principal investigator, Recep Tayyip Erdogan University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251599
- Sponsor's protocol ID
- 2017/5
- Acronym
- nitrotherm
- Status last verified
- Dec 2023
- First submitted
- 1 Aug 2017
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8763414Michenfelder 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.
PubMed 2064037Hori 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.
PubMed 26163357Engelman 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.
PubMed 27106452Grigore 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.
PubMed 11772792
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Rates of Nitroglycerin Infusion on Cerebral Rewarming During Rewarming Period of Hypothermic Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03251599
- Acronym / sponsor ID
- nitrotherm / 2017/5
- Conditions
- Coronary Artery Bypass, Cardiopulmonary Bypass
- Keywords
- peak temperature, rewarming rate, surgical outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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.
Glyceryl trinitrate is used in coronary artery bypass grafting surgery. This surgery frequently employs hypothermic cardiopulmonary bypass, where the whole body is cooled down to 28-32 °C to arrest the heart, and protect the organs from ischemic insult. When the cardiac repair or grafting is done, the body is warmed to 37 °C. During this "rewarming period", the heart has to beat against the vessels, all of which are constricted due to hypothermia.
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
Hypothermia had demonstrated potential benefits in myocardial infarction, organ transplantation, and cardiopulmonary bypass. The brain uses 2/3 of the oxygen it receives to support cerebral electrophysiological function, while the rest is used for maintenance of cellular integrity. Anesthetic drugs alter only the first portion, while temperature is the only agent known to affect both portions (the cerebral consumption of oxygen decreases 6-7 % per degree centigrade reduction in temperature).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention type is drug dosage. Patients will be assigned to 2 arms, where they will receive different doses of the same drug. The study will end when both of the arms will have at least 48 patients each.
| Arm | Type | Receives |
|---|---|---|
| Glyceryl trinitrate 0.2 | Sham comparator | Drug: Glyceryl trinitrate 0.2Drug 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 0.5 | Active comparator | Drug: Glyceryl trinitrate 0.5Drug 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are scheduled for on-pump coronary artery bypass grafting surgery
Key exclusion criteria (1 listed)
- Administration of vasopressors during rewarming period
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 |
|---|---|---|
| Glyceryl trinitrate 0.2Also: Nitroglycerin, PerlinganitThese 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. | Drug | Glyceryl trinitrate 0.2 |
| Glyceryl trinitrate 0.5Also: Nitroglycerin, PerlinganitThese 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. | Drug | Glyceryl trinitrate 0.5 |
Primary outcome
Nasopharyngeal temperature > 37 °C
Time frame: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
If the nasopharyngeal temperature is > 37 °C by the time the esophageal temperature reached 37 °C.
Time to 37 °C
Time frame: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
Time required to reach an esophageal temperature of 37 °C.
7 secondary outcomes
Adverse event: Regional cerebral oxygen saturation
Time frame: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
Length of Intensive Care Unit stay
Time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from Intensive Care Unit, whichever came first, assessed up to 1 month
Length of hospital stay
Time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of atrial fibrillation
Time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of low cardiac output syndrome
Time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of stroke
Time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
Frequency of delirium
Time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
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 22 Dec 2023.
- Background: PubMed 8763414Johansson 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.
- Background: PubMed 2064037Michenfelder 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.
- Background: PubMed 26163357Hori 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.
- Background: PubMed 27106452Engelman 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.
- Background: PubMed 11772792Grigore 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.
- Individual participant dataSharing planned: No
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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.
Başar Erdivanlı, M.D. principal investigator
Recep Tayyip Erdogan University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glyceryl trinitrate 0.2 and Glyceryl trinitrate 0.5 in people with Coronary Artery Bypass and Cardiopulmonary Bypass, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 1 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 22 Dec 2023. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nasopharyngeal temperature > 37 °C (time frame: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes). The study lists 2 primary outcomes in all. 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 NCT03251599, which also lists 5 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 22 Dec 2023.