Cardiac Surgery Clinical Trial
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
Verified date | January 2020 |
Source | Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | September 30, 2014 |
Est. primary completion date | August 31, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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%. Exclusion Criteria: - 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), - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital | Trakya University Faculty of Medicine Hospital |
Cuthbertson 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. — View Citation
Cuthbertson 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. — View Citation
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. Anesth — View Citation
Fox 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 — View Citation
Hutfless 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 — View Citation
Karthikeyan 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 — View Citation
Litton 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 — View Citation
Lurati 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: 10.1 — View Citation
Murad 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. — View Citation
Uhlig 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 Undergoi — View Citation
Yun 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum BNP values before the cardiac surgery | Serum BNP values were collected from a blood sample of each patient one day before cardiac surgery | One day before cardiac surgery. | |
Primary | 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 | After operation at 24 hours after cardiac surgery. | |
Primary | 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 | After operation at 48 hours after cardiac surgery. | |
Primary | 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 | After operation at 72 hours after cardiac surgery. | |
Primary | Serum BNP values before and after the cardiac surgery | The collected serum BNP values were compared with each other by repeated measure analysis | After collection of the data and during statistical analysis | |
Secondary | Outcome aortic cross-clamp time | A relation between serum BNP values and aortic cross-clamp time | During operative time period of cardiac surgery | |
Secondary | Outcome cardiopulmonary bypass time | A relation between serum BNP values and cardiopulmonary bypass time | During operative time period of cardiac surgery | |
Secondary | Outcome use of inotropic support | A relation between serum BNP values and use of inotropic support | During operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome use of Intra-aortic balloon pump | A relation between serum BNP values and use of Intra-aortic balloon pump | During operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome duration of mechanical ventilation (>48 hours) | A relation between serum BNP values and duration of mechanical ventilation (>48 hours) | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome development of pneumonia | A relation between serum BNP values and development of pneumonia | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome parameters | A relation between serum BNP values and perioperative myocardial infarction | During operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome cerebrovascular event or seizure | A relation between serum BNP values and cerebrovascular event (stroke or transient ischemic attack) or seizure | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome atrial rhythm disturbances | A relation between serum BNP values and atrial fibrillation and other atrial rhythm disturbances | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome ventricular rhythm disturbances | A relation between serum BNP values and ventricular rhythm disturbances | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome renal replacement therapy | A relation between serum BNP values and need for renal replacement therapy (RRT) | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome reoperation | A relation between serum BNP values and reoperation secondary to bleeding | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome intensive care unit stay | A relation between serum BNP values and intensive care unit stay (>3 days) | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome hospital stay | A relation between serum BNP values and intensive care unit stay (>3 days) | After operative time period of cardiac surgery and during intensive care unit stay | |
Secondary | Outcome thirty-day mortality | A relation between serum BNP values and thirty-day mortality | After operative time period of cardiac surgery and during intensive care unit stay |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04051021 -
Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
|
N/A | |
Recruiting |
NCT04604886 -
The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
|
N/A | |
Recruiting |
NCT04075981 -
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
|
Phase 3 | |
Completed |
NCT04062396 -
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
|
N/A | |
Recruiting |
NCT04709705 -
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05563662 -
SURgical Registry of ENDocarditis EuRope
|
||
Withdrawn |
NCT03289104 -
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
|
N/A | |
Completed |
NCT04199039 -
Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
|
N/A | |
Completed |
NCT02964026 -
Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
|
N/A | |
Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
Completed |
NCT02471001 -
The Levels of Anaesthetics in Heart Muscle During Heart Surgery
|
N/A | |
Completed |
NCT02325726 -
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
|
N/A | |
Completed |
NCT01246947 -
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
|
N/A | |
Completed |
NCT01151254 -
Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
|
N/A | |
Completed |
NCT00821262 -
Sevoflurane in Cardiac Surgery
|
Phase 4 | |
Completed |
NCT00996099 -
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
|
N/A | |
Completed |
NCT00617955 -
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
|
N/A | |
Completed |
NCT00336466 -
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)
|
Phase 2 | |
Completed |
NCT00337805 -
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
|
Phase 2/Phase 3 |