Brain Natriuretic PeptideNCT04238806
Desflurane,Brain Natriuretic Peptide and Cardiac Surgery
A study testing Desflurane Inhalational agent in people with Brain Natriuretic Peptide and Coronary Artery Bypass Graft Surgery, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
Trial summary
During coronary artery bypass grafting (CABG) operations with cardiopulmonary bypass (CPB), the use of desflurane continuously or intermittently may have effects on serum brain natriuretic peptide (BNP) levels. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Natriuretic Peptide, Coronary Artery Bypass Graft Surgery, Cardiac Surgery
- What is being tested?
- Desflurane Inhalational agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 30 Sep 2014
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen to seventy-five years of age,
- Body mass index values between twenty-five and thirty-one,
- Ejection fraction greater than or equal to 50%.
Who cannot join
- Repeat cardiac surgery,
- Emergent surgery,
- Preoperative coagulation disorder,
- Preoperative congestive heart failure,
- Ejection fraction less than 49%,
- Preoperative renal dysfunction (serum creatinine value of greater than 1.3 mg/dL),
Show all 11Show fewer
- Dialysis,
- Preoperative hepatic dysfunction (serum aspartate/alanine amino transferase values of greater than 40 U/L),
- Preoperative electrolyte imbalance,
- History of pancreatitis,
- Current corticosteroid treatment.
About this study
Official title: An Investigation of the Association Between Desflurane Inhalational Agent, Serum Brain Natriuretic Peptide (BNP) Levels and Clinical Outcomes During Coronary Artery Bypass Graft (CABG) Surgery
During coronary artery bypass grafting (CABG) operations with cardiopulmonary bypass (CPB), the use of desflurane continuously or intermittently may have effects on serum brain natriuretic peptide (BNP) levels. The aim is to investigate the association between desflurane, serum BNP values, and clinical outcomes during CABG operations. In a prospective, randomized, double-blinded study, desflurane inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60 versus Group 2; n=62). The preoperative and postoperative BNP levels at 24, 48 and 72 hours after surgery were collected. Outcomes were recorded.
Read the detailed description
Background: During coronary artery bypass grafting (CABG) operations with cardiopulmonary bypass (CPB), the use of desflurane continuously or intermittently may have effects on serum brain natriuretic peptide (BNP) levels.
Aim of the study: The aim is to investigate the association between desflurane, serum BNP values, and clinical outcomes during CABG operations.
Material and methods: In a prospective, randomized, double-blinded study, desflurane inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60 versus Group 2; n=62). The preoperative and postoperative BNP levels at 24, 48 and 72 hours after surgery were collected. Outcomes were recorded. Randomization into two groups was performed using sealed envelopes. The sequentially numbered assignments of participants were concealed in these envelopes during the study. The patients enrolled in the study receive an allocation to a group after anesthesia induction by health care personnel after the opening of the envelope. The observers were blinded to the anesthetic protocol. Caregivers were not blinded, but they did not participate in data collection or data interpretation. Therefore, the study protocol is considered double-blinded, masked to observers. Inclusion criteria include; 18 to 75 years of age, body mass index of 25 to 31, ejection fraction≥50%. Exclusion criteria include; repeat cardiac surgery, emergent surgery, preoperative coagulation disorder, preoperative congestive heart failure, ejection fraction <49%, preoperative renal dysfunction (serum creatinine>1.3 mg/dL), dialysis, preoperative hepatic dysfunction (serum aspartate/alanine amino transferase>40 U/L), preoperative electrolyte imbalance, history of pancreatitis or current corticosteroid treatment.The primary endpoint was to determine preoperative and postoperative BNP values 24, 48 and 72 hours after surgery. The secondary endpoint was the relation between BNP values and clinical outcomes such as; 1-Aortic cross-clamp time, 2-Cardiopulmonary bypass time, 3-The use of inotropic support, 4-Intra-aortic balloon pump, 5-Duration of mechanical ventilation (>48 hours), 6-Development of pneumonia, 7-Perioperative myocardial infarction, 8-Cerebrovascular event (stroke or transient ischemic attack), seizure, 9-Atrial fibrillation and other rhythm disturbances, 10-Need for renal replacement therapy (RRT), 11-Reoperation secondary to bleeding, 12-Intensive care unit stay (>3 days), 13-Hospital stay and, 14-Thirty-day mortality.
Statistical analysis. The sample size was calculated according to the comparison of serum BNP values in a previous study and a sample size of 58 patients per group would be required with 80% power and the conventional 2-sided type 1 error of 5%. A multiple logistic regression analysis was performed to assess the predictive factors for weaning failure from mechanical ventilation, and the significance level was set at a p-value of less than 0.10 in the univariate model. To determine the best cut-off for preoperative BNP value to predict the development of prolonged mechanical ventilation, we calculated the area under the receiver operating characteristic curve.
- Conditions
- Brain Natriuretic Peptide, Coronary Artery Bypass Graft Surgery, Cardiac Surgery, Cardiopulmonary Bypass, Desflurane, Outcome
- Being tested
- Desflurane Inhalational agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane Inhalational agentDrug
Also called Suprane
Desflurane inhalational agent administration during the whole cardiac surgical operation with cardiopulmonary bypass versus administration of desflurane inhalational agent before and after cardiopulmonary bypass during the whole period of cardiac surgical operation.
| Study group | Role | What they receive |
|---|---|---|
| Desflurane Continuous | Active comparator | In Group 1 of 60 patients, desflurane inhalational agent was administered continuously during coronary artery bypass graft surgery with cardiopulmonary bypass. Anesthesia induction was administered to all patients with intravenous midazolam at a dose of 0.2 mg/kg, fentanyl at a dose of 5 to 10 µg/kg and rocuronium bromide at a dose of 0.1 mg. For maintenance, in Group 1 patients, desflurane inhalational agent was administered at an end-tidal concentration of 1 to 4% during the whole surgical procedure and intravenous maintenance midazolam at a dose of 0.03 mg/kg and fentanyl at a dose of 1 to 2 µg/kg every half an hour. In Group 1 of patients, during the whole surgical procedure, attention to keep mean arterial pressure above 50 mmHg was provided. Receives: Drug: Desflurane Inhalational agent |
| Desflurane Intermittent | Active comparator | In Group 2 of 60 patients, desflurane inhalational agent was administered intermittently during coronary artery bypass graft surgery with cardiopulmonary bypass. Anesthesia induction was administered to all patients with intravenous midazolam at a dose of 0.2 mg/kg, fentanyl at a dose of 5 to 10 µg/kg and rocuronium bromide at a dose of 0.1 mg/kg. For maintenance, in Group 2 patients, desflurane inhalational agent was administered at an end-tidal concentration of 1 to 4% before and after the cardiopulmonary bypass procedure as intermittently with the addition of intravenous maintenance midazolam at a dose of 0.03 mg/kg and fentanyl at a dose of 1 to 2 µg/kg every half an hour. In Group 2 of patients, during the whole surgical procedure, attention to keep mean arterial pressure above 50 mmHg was provided. Receives: Drug: Desflurane Inhalational agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum BNP values before the cardiac surgery
Serum BNP values were collected from a blood sample of each patient one day before cardiac surgery
Measured: One day before cardiac surgery.
Serum BNP values after the cardiac surgery at 24 hours
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
Measured: After operation at 24 hours after cardiac surgery.
Serum BNP values after the cardiac surgery at 48 hours
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
Measured: After operation at 48 hours after cardiac surgery.
Serum BNP values after the cardiac surgery at 72 hours
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
Measured: After operation at 72 hours after cardiac surgery.
Serum BNP values before and after the cardiac surgery
The collected serum BNP values were compared with each other by repeated measure analysis
Measured: After collection of the data and during statistical analysis
Secondary outcomes (15)
Outcome aortic cross-clamp time
A relation between serum BNP values and aortic cross-clamp time
Measured: During operative time period of cardiac surgery
Outcome cardiopulmonary bypass time
A relation between serum BNP values and cardiopulmonary bypass time
Measured: During operative time period of cardiac surgery
Outcome use of inotropic support
A relation between serum BNP values and use of inotropic support
Measured: During operative time period of cardiac surgery and during intensive care unit stay
Outcome use of Intra-aortic balloon pump
A relation between serum BNP values and use of Intra-aortic balloon pump
Measured: During operative time period of cardiac surgery and during intensive care unit stay
Outcome duration of mechanical ventilation (>48 hours)
A relation between serum BNP values and duration of mechanical ventilation (>48 hours)
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome development of pneumonia
A relation between serum BNP values and development of pneumonia
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome parameters
A relation between serum BNP values and perioperative myocardial infarction
Measured: During operative time period of cardiac surgery and during intensive care unit stay
Outcome cerebrovascular event or seizure
A relation between serum BNP values and cerebrovascular event (stroke or transient ischemic attack) or seizure
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome atrial rhythm disturbances
A relation between serum BNP values and atrial fibrillation and other atrial rhythm disturbances
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome ventricular rhythm disturbances
A relation between serum BNP values and ventricular rhythm disturbances
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome renal replacement therapy
A relation between serum BNP values and need for renal replacement therapy (RRT)
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome reoperation
A relation between serum BNP values and reoperation secondary to bleeding
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome intensive care unit stay
A relation between serum BNP values and intensive care unit stay (>3 days)
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome hospital stay
A relation between serum BNP values and intensive care unit stay (>3 days)
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Outcome thirty-day mortality
A relation between serum BNP values and thirty-day mortality
Measured: After operative time period of cardiac surgery and during intensive care unit stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Sep 2013
- Primary completion31 Aug 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain Natriuretic PeptideStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a prospective, randomized, double-blinded study, desflurane inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60 versus Group 2; n=62).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Trakya University Faculty of Medicine Hospital
- Responsible party
- Principal investigator, Ayse Baysal, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Investigators
- Gonul Sagiroglu, MD, Study director, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238806
- Sponsor's protocol ID
- 2013.3/13
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD sharing plan includes sharing of the Study Protocol, Statistical Analysis Plan, and Statistical Analysis of the study with researchers upon request via e-mail.
Publications
De Hert SG, Cromheecke S, ten Broecke PW, Mertens E, De Blier IG, Stockman BA, Rodrigus IE, Van der Linden PJ. Effects of propofol, desflurane, and sevoflurane on recovery of myocardial function after coronary surgery in elderly high-risk patients. Anesthesiology. 2003 Aug;99(2):314-23. doi: 10.1097/00000542-200308000-00013.
PubMed 12883404Cuthbertson BH, Amiri AR, Croal BL, Rajagopalan S, Alozairi O, Brittenden J, Hillis GS. Utility of B-type natriuretic peptide in predicting perioperative cardiac events in patients undergoing major non-cardiac surgery. Br J Anaesth. 2007 Aug;99(2):170-6. doi: 10.1093/bja/aem158. Epub 2007 Jun 15.
PubMed 17573389Karthikeyan G, Moncur RA, Levine O, Heels-Ansdell D, Chan MT, Alonso-Coello P, Yusuf S, Sessler D, Villar JC, Berwanger O, McQueen M, Mathew A, Hill S, Gibson S, Berry C, Yeh HM, Devereaux PJ. Is a pre-operative brain natriuretic peptide or N-terminal pro-B-type natriuretic peptide measurement an independent predictor of adverse cardiovascular outcomes within 30 days of noncardiac surgery? A systematic review and meta-analysis of observational studies. J Am Coll Cardiol. 2009 Oct 20;54(17):1599-606. doi: 10.1016/j.jacc.2009.06.028.
PubMed 19833258Uhlig C, Bluth T, Schwarz K, Deckert S, Heinrich L, De Hert S, Landoni G, Serpa Neto A, Schultz MJ, Pelosi P, Schmitt J, Gama de Abreu M. Effects of Volatile Anesthetics on Mortality and Postoperative Pulmonary and Other Complications in Patients Undergoing Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2016 Jun;124(6):1230-45. doi: 10.1097/ALN.0000000000001120.
PubMed 27065094Yun KH, Jeong MH, Oh SK, Choi JH, Rhee SJ, Park EM, Yoo NJ, Kim NH, Ahn YK, Jeong JW. Preoperative plasma N-terminal pro-brain natriuretic peptide concentration and perioperative cardiovascular risk in elderly patients. Circ J. 2008 Feb;72(2):195-9. doi: 10.1253/circj.72.195.
PubMed 18219153Fox AA, Nascimben L, Body SC, Collard CD, Mitani AA, Liu KY, Muehlschlegel JD, Shernan SK, Marcantonio ER. Increased perioperative b-type natriuretic peptide associates with heart failure hospitalization or heart failure death after coronary artery bypass graft surgery. Anesthesiology. 2013 Aug;119(2):284-94. doi: 10.1097/ALN.0b013e318299969c.
PubMed 23695172Litton E, Ho KM. The use of pre-operative brain natriuretic peptides as a predictor of adverse outcomes after cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Mar;41(3):525-34. doi: 10.1093/ejcts/ezr007. Epub 2011 Oct 20.
PubMed 22345176Hutfless R, Kazanegra R, Madani M, Bhalla MA, Tulua-Tata A, Chen A, Clopton P, James C, Chiu A, Maisel AS. Utility of B-type natriuretic peptide in predicting postoperative complications and outcomes in patients undergoing heart surgery. J Am Coll Cardiol. 2004 May 19;43(10):1873-9. doi: 10.1016/j.jacc.2003.12.048.
PubMed 15145114Murad Junior JA, Nakazone MA, Machado Mde N, Godoy MF. Predictors of mortality in cardiac surgery: brain natriuretic peptide type B. Rev Bras Cir Cardiovasc. 2015 Mar-Apr;30(2):182-7. doi: 10.5935/1678-9741.20150008.
PubMed 26107449Lurati Buse GA, Koller MT, Burkhart C, Seeberger MD, Filipovic M. The predictive value of preoperative natriuretic peptide concentrations in adults undergoing surgery: a systematic review and meta-analysis. Anesth Analg. 2011 May;112(5):1019-33. doi: 10.1213/ANE.0b013e31820f286f. Epub 2011 Mar 3.
PubMed 21372274Cuthbertson BH, Croal BL, Rae D, Gibson PH, McNeilly JD, Jeffrey RR, Smith WC, Prescott GJ, Buchan KG, El-Shafei H, Gibson GA, Hillis GS. N-terminal pro-B-type natriuretic peptide levels and early outcome after cardiac surgery: a prospective cohort study. Br J Anaesth. 2009 Nov;103(5):647-53. doi: 10.1093/bja/aep234. Epub 2009 Aug 27.
PubMed 19713279
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Association Between Desflurane Inhalational Agent, Serum Brain Natriuretic Peptide (BNP) Levels and Clinical Outcomes During Coronary Artery Bypass Graft (CABG) Surgery
- ClinicalTrials.gov ID
- NCT04238806
- Acronym / sponsor ID
- 2013.3/13
- Conditions
- Brain Natriuretic Peptide, Coronary Artery Bypass Graft Surgery, Cardiac Surgery, Cardiopulmonary Bypass, Desflurane, Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Collaborators
- Trakya University Faculty of Medicine Hospital
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 23 Jan 2020 (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.
During coronary artery bypass grafting (CABG) operations with cardiopulmonary bypass (CPB), the use of desflurane continuously or intermittently may have effects on serum brain natriuretic peptide (BNP) levels. The aim is to investigate the association between desflurane, serum BNP values, and clinical outcomes during CABG operations. In a prospective, randomized, double-blinded study, desflurane inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60 versus Group 2; n=62). The preoperative and postoperative BNP levels at 24, 48 and 72 hours after surgery were collected. Outcomes were recorded.
Detailed description
Background: During coronary artery bypass grafting (CABG) operations with cardiopulmonary bypass (CPB), the use of desflurane continuously or intermittently may have effects on serum brain natriuretic peptide (BNP) levels.
Aim of the study: The aim is to investigate the association between desflurane, serum BNP values, and clinical outcomes during CABG operations.
Material and methods: In a prospective, randomized, double-blinded study, desflurane inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60 versus Group 2; n=62). The preoperative and postoperative BNP levels at 24, 48 and 72 hours after surgery were collected. Outcomes were recorded. Randomization into two groups was performed using sealed envelopes. The sequentially numbered assignments of participants were concealed in these envelopes during the study. The patients enrolled in the study receive an allocation to a group after anesthesia induction by health care personnel after the opening of the envelope. The observers were blinded to the anesthetic protocol. Caregivers were not blinded, but they did not participate in data collection or data interpretation. Therefore, the study protocol is considered double-blinded, masked to observers. Inclusion criteria include; 18 to 75 years of age, body mass index of 25 to 31, ejection fraction≥50%. Exclusion criteria include; repeat cardiac surgery, emergent surgery, preoperative coagulation disorder, preoperative congestive heart failure, ejection fraction <49%, preoperative renal dysfunction (serum creatinine>1.3 mg/dL), dialysis, preoperative hepatic dysfunction (serum aspartate/alanine amino transferase>40 U/L), preoperative electrolyte imbalance, history of pancreatitis or current corticosteroid treatment.The primary endpoint was to determine preoperative and postoperative BNP values 24, 48 and 72 hours after surgery. The secondary endpoint was the relation between BNP values and clinical outcomes such as; 1-Aortic cross-clamp time, 2-Cardiopulmonary bypass time, 3-The use of inotropic support, 4-Intra-aortic balloon pump, 5-Duration of mechanical ventilation (>48 hours), 6-Development of pneumonia, 7-Perioperative myocardial infarction, 8-Cerebrovascular event (stroke or transient ischemic attack), seizure, 9-Atrial fibrillation and other rhythm disturbances, 10-Need for renal replacement therapy (RRT), 11-Reoperation secondary to bleeding, 12-Intensive care unit stay (>3 days), 13-Hospital stay and, 14-Thirty-day mortality.
Statistical analysis. The sample size was calculated according to the comparison of serum BNP values in a previous study and a sample size of 58 patients per group would be required with 80% power and the conventional 2-sided type 1 error of 5%. A multiple logistic regression analysis was performed to assess the predictive factors for weaning failure from mechanical ventilation, and the significance level was set at a p-value of less than 0.10 in the univariate model. To determine the best cut-off for preoperative BNP value to predict the development of prolonged mechanical ventilation, we calculated the area under the receiver operating characteristic curve.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- In a prospective, randomized, double-blinded study, desflurane inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60 versus Group 2; n=62).
| Arm | Type | Receives |
|---|---|---|
| Desflurane Continuous | Active comparator | Drug: Desflurane Inhalational agentIn Group 1 of 60 patients, desflurane inhalational agent was administered continuously during coronary artery bypass graft surgery with cardiopulmonary bypass. Anesthesia induction was administered to all patients with intravenous midazolam at a dose of 0.2 mg/kg, fentanyl at a dose of 5 to 10 µg/kg and rocuronium bromide at a dose of 0.1 mg. For maintenance, in Group 1 patients, desflurane inhalational agent was administered at an end-tidal concentration of 1 to 4% during the whole surgical procedure and intravenous maintenance midazolam at a dose of 0.03 mg/kg and fentanyl at a dose of 1 to 2 µg/kg every half an hour. In Group 1 of patients, during the whole surgical procedure, attention to keep mean arterial pressure above 50 mmHg was provided. |
| Desflurane Intermittent | Active comparator | Drug: Desflurane Inhalational agentIn Group 2 of 60 patients, desflurane inhalational agent was administered intermittently during coronary artery bypass graft surgery with cardiopulmonary bypass. Anesthesia induction was administered to all patients with intravenous midazolam at a dose of 0.2 mg/kg, fentanyl at a dose of 5 to 10 µg/kg and rocuronium bromide at a dose of 0.1 mg/kg. For maintenance, in Group 2 patients, desflurane inhalational agent was administered at an end-tidal concentration of 1 to 4% before and after the cardiopulmonary bypass procedure as intermittently with the addition of intravenous maintenance midazolam at a dose of 0.03 mg/kg and fentanyl at a dose of 1 to 2 µg/kg every half an hour. In Group 2 of patients, during the whole surgical procedure, attention to keep mean arterial pressure above 50 mmHg was provided. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eighteen to seventy-five years of age,
- Body mass index values between twenty-five and thirty-one,
- Ejection fraction greater than or equal to 50%.
Key exclusion criteria (11 listed)
- Repeat cardiac surgery,
- Emergent surgery,
- Preoperative coagulation disorder,
- Preoperative congestive heart failure,
- Ejection fraction less than 49%,
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 |
|---|---|---|
| Desflurane Inhalational agentAlso: SupraneDesflurane inhalational agent administration during the whole cardiac surgical operation with cardiopulmonary bypass versus administration of desflurane inhalational agent before and after cardiopulmonary bypass during the whole period of cardiac surgical operation. | Drug | Desflurane Continuous, Desflurane Intermittent |
Primary outcome
Serum BNP values before the cardiac surgery
Time frame: One day before cardiac surgery.
Serum BNP values were collected from a blood sample of each patient one day before cardiac surgery
Serum BNP values after the cardiac surgery at 24 hours
Time frame: After operation at 24 hours after cardiac surgery.
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
Serum BNP values after the cardiac surgery at 48 hours
Time frame: After operation at 48 hours after cardiac surgery.
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
Serum BNP values after the cardiac surgery at 72 hours
Time frame: After operation at 72 hours after cardiac surgery.
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
Serum BNP values before and after the cardiac surgery
Time frame: After collection of the data and during statistical analysis
The collected serum BNP values were compared with each other by repeated measure analysis
15 secondary outcomes
Outcome aortic cross-clamp time
Time frame: During operative time period of cardiac surgery
Outcome cardiopulmonary bypass time
Time frame: During operative time period of cardiac surgery
Outcome use of inotropic support
Time frame: During operative time period of cardiac surgery and during intensive care unit stay
Outcome use of Intra-aortic balloon pump
Time frame: During operative time period of cardiac surgery and during intensive care unit stay
Outcome duration of mechanical ventilation (>48 hours)
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome development of pneumonia
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome parameters
Time frame: During operative time period of cardiac surgery and during intensive care unit stay
Outcome cerebrovascular event or seizure
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome atrial rhythm disturbances
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome ventricular rhythm disturbances
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome renal replacement therapy
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome reoperation
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome intensive care unit stay
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome hospital stay
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
Outcome thirty-day mortality
Time frame: After operative time period of cardiac surgery and during intensive care unit stay
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 23 Jan 2020.
- Results publication: PubMed 12883404De Hert SG, Cromheecke S, ten Broecke PW, Mertens E, De Blier IG, Stockman BA, Rodrigus IE, Van der Linden PJ. Effects of propofol, desflurane, and sevoflurane on recovery of myocardial function after coronary surgery in elderly high-risk patients. Anesthesiology. 2003 Aug;99(2):314-23. doi: 10.1097/00000542-200308000-00013.
- Results publication: PubMed 17573389Cuthbertson BH, Amiri AR, Croal BL, Rajagopalan S, Alozairi O, Brittenden J, Hillis GS. Utility of B-type natriuretic peptide in predicting perioperative cardiac events in patients undergoing major non-cardiac surgery. Br J Anaesth. 2007 Aug;99(2):170-6. doi: 10.1093/bja/aem158. Epub 2007 Jun 15.
- Results publication: PubMed 19833258Karthikeyan G, Moncur RA, Levine O, Heels-Ansdell D, Chan MT, Alonso-Coello P, Yusuf S, Sessler D, Villar JC, Berwanger O, McQueen M, Mathew A, Hill S, Gibson S, Berry C, Yeh HM, Devereaux PJ. Is a pre-operative brain natriuretic peptide or N-terminal pro-B-type natriuretic peptide measurement an independent predictor of adverse cardiovascular outcomes within 30 days of noncardiac surgery? A systematic review and meta-analysis of observational studies. J Am Coll Cardiol. 2009 Oct 20;54(17):1599-606. doi: 10.1016/j.jacc.2009.06.028.
- Results publication: PubMed 27065094Uhlig C, Bluth T, Schwarz K, Deckert S, Heinrich L, De Hert S, Landoni G, Serpa Neto A, Schultz MJ, Pelosi P, Schmitt J, Gama de Abreu M. Effects of Volatile Anesthetics on Mortality and Postoperative Pulmonary and Other Complications in Patients Undergoing Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2016 Jun;124(6):1230-45. doi: 10.1097/ALN.0000000000001120.
- Results publication: PubMed 18219153Yun KH, Jeong MH, Oh SK, Choi JH, Rhee SJ, Park EM, Yoo NJ, Kim NH, Ahn YK, Jeong JW. Preoperative plasma N-terminal pro-brain natriuretic peptide concentration and perioperative cardiovascular risk in elderly patients. Circ J. 2008 Feb;72(2):195-9. doi: 10.1253/circj.72.195.
- Results publication: PubMed 23695172Fox AA, Nascimben L, Body SC, Collard CD, Mitani AA, Liu KY, Muehlschlegel JD, Shernan SK, Marcantonio ER. Increased perioperative b-type natriuretic peptide associates with heart failure hospitalization or heart failure death after coronary artery bypass graft surgery. Anesthesiology. 2013 Aug;119(2):284-94. doi: 10.1097/ALN.0b013e318299969c.
- Results publication: PubMed 22345176Litton E, Ho KM. The use of pre-operative brain natriuretic peptides as a predictor of adverse outcomes after cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Mar;41(3):525-34. doi: 10.1093/ejcts/ezr007. Epub 2011 Oct 20.
- Results publication: PubMed 15145114Hutfless R, Kazanegra R, Madani M, Bhalla MA, Tulua-Tata A, Chen A, Clopton P, James C, Chiu A, Maisel AS. Utility of B-type natriuretic peptide in predicting postoperative complications and outcomes in patients undergoing heart surgery. J Am Coll Cardiol. 2004 May 19;43(10):1873-9. doi: 10.1016/j.jacc.2003.12.048.
- Results publication: PubMed 26107449Murad Junior JA, Nakazone MA, Machado Mde N, Godoy MF. Predictors of mortality in cardiac surgery: brain natriuretic peptide type B. Rev Bras Cir Cardiovasc. 2015 Mar-Apr;30(2):182-7. doi: 10.5935/1678-9741.20150008.
- Results publication: PubMed 21372274Lurati Buse GA, Koller MT, Burkhart C, Seeberger MD, Filipovic M. The predictive value of preoperative natriuretic peptide concentrations in adults undergoing surgery: a systematic review and meta-analysis. Anesth Analg. 2011 May;112(5):1019-33. doi: 10.1213/ANE.0b013e31820f286f. Epub 2011 Mar 3.
- Results publication: PubMed 19713279Cuthbertson BH, Croal BL, Rae D, Gibson PH, McNeilly JD, Jeffrey RR, Smith WC, Prescott GJ, Buchan KG, El-Shafei H, Gibson GA, Hillis GS. N-terminal pro-B-type natriuretic peptide levels and early outcome after cardiac surgery: a prospective cohort study. Br J Anaesth. 2009 Nov;103(5):647-53. doi: 10.1093/bja/aep234. Epub 2009 Aug 27.
- Individual participant dataSharing planned: Yes. IPD sharing plan includes sharing of the Study Protocol, Statistical Analysis Plan, and Statistical Analysis of the study with researchers upon request via e-mail.
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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.
Gonul Sagiroglu, MD study director
Trakya University
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane Inhalational agent in people with Brain Natriuretic Peptide and Coronary Artery Bypass Graft Surgery, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
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 3 inclusion and 11 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 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Serum BNP values before the cardiac surgery (time frame: One day before cardiac surgery.). The study lists 5 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 NCT04238806, which also lists 11 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 23 Jan 2020.