Intraoperative Insulin Infusion Regimen versus Insulin Bolus Regimen for Glucose Management during CABG Surgery: A Randomized Clinical Trial
Intraoperative Insulin Infusion Regimen versus Insulin Bolus Regimen
DOI:
https://doi.org/10.35516/jjps.v16i3.708Keywords:
Type 2 diabetes mellitus, cardiac surgery, glucose levels, insulin infusion, insulin bolusAbstract
Background and Aim: The stress induced by surgery disrupts the delicate balance between hepatic glucose production and glucose utilization in the body. Despite the significance of intraoperative glycaemic control for diabetic patients, limited attention has been given to this aspect. Two methods for administering insulin to manage glucose levels during surgery exist. This study aimed to compare intraoperative glucose levels in diabetic patients undergoing Coronary Artery Bypass Graft (CABG) surgery using either insulin infusion or the bolus method.
Method: This was a Randomized Clinical Trial (RCT). Seventy diabetic patients aged 40 or older scheduled for CABG surgery were enrolled in the trial. They were randomly assigned, using block randomization, to receive intraoperative insulin via either infusion or the bolus method. The primary outcome measure was intraoperative glucose levels. Subsequent insulin unit requirements and intraoperative potassium levels were secondary outcomes. Data was monitored throughout the CABG procedure and recorded at six different checkpoints.
Results: Male patients constituted the majority in both groups, with no significant differences in the preoperative characteristics of patients, including HbA1c levels and comorbidities. The infusion regimen demonstrated a statistically significant reduction in glucose levels (-19.12 mg/dL, 95% CI: -27.68 to -10.55, P<0.001, Cohen's d=1.06) compared to the bolus regimen. The total insulin units administered in the infusion group were 480 units, as opposed to 600 units in the bolus group (P=0.001, Cohen's d=0.85). Importantly, no cases of hypoglycemia or hyperkalemia were reported among the patients.
Conclusion: Intraoperative glucose control using insulin was effective for CABG patients with diabetes. However, the infusion regimen exhibited statistically superior results compared to the bolus regimen.
Clinical Trials Registry and Registration Number: The trial received approval from the Ethics Committee on 2/1/2019/2020 and was registered on Clinicaltrials.gov under ID: NCT04824586.
References
Sathya B., Davis R., Taveira T., Whitlatch H., Wu WC. Intensity of peri-operative glycemic control and postoperative outcomes in patients with diabetes: a meta-analysis. Diabetes Res Clin Pract, 2013; 102(1): 8-15. doi: 10.1016/j.diabres.2013.05.003 DOI: https://doi.org/10.1016/j.diabres.2013.05.003
Shah NJ., Leis A., Kheterpal S., Englesbe MJ., Kumar SS. Association of intraoperative hyperglycemia and postoperative outcomes in patients undergoing non-cardiac surgery: a multicenter retrospective study. BMC Anesthesiol. 2020; 20: 106.
https://doi.org/10.1186/s12871-020-01022-w DOI: https://doi.org/10.1186/s12871-020-01022-w
Gandhi GY., Nuttall GA., Abel MD., Mullany CJ., Schaff HV., Williams BA., Schrader LM., Rizza RA., McMahon MM. Intraoperative Hyperglycemia and Perioperative Outcomes in Cardiac Surgery Patients. Mayo Clin Proc, 2005; 80(7): 862–866. DOI: https://doi.org/10.4065/80.7.862
Abuloha S., Alabbadi I., Albsoul-Younes A., Younes N., Zayed A. The Role of Clinical Pharmacist in Initiation and/or Dose Adjustment of Insulin Therapy in Diabetic Patients in Outpatient Clinic in Jordan. Jordan J Pharm Sci. 2016; 9(1): 33–50. DOI: https://doi.org/10.12816/0029869
Hua J., Chen G., Li H., Fu S., Zhang LM., Scott M., Li Q. Intensive Intraoperative Insulin Therapy Versus Conventional Insulin Therapy During Cardiac Surgery: A Meta-Analysis. J Cardiothorac Vasc Anesth. 2012; 26(5): 829–834. DOI: https://doi.org/10.1053/j.jvca.2011.12.016
Omar S., Albsoul A., Alabbadi I. Hypoglycaemia Fear among Diabetics. Jordan J Pharm Sci. 2016; 9(2): 77–88. DOI: https://doi.org/10.12816/0033307
Duncan AE., Abd-Elsayed A., Maheshwari A., Xu M., Soltesz E., Koch CG. Role of Intraoperative and Postoperative Blood Glucose Concentrations in Predicting Outcomes after Cardiac Surgery. Anesthesiology, 2010; 112(4): 860–871. DOI: https://doi.org/10.1097/ALN.0b013e3181d3d4b4
Lazar HL. Glycemic Control during Coronary Artery Bypass Graft Surgery. ISRN Cardiol, 2012. doi:10.5402/2012/292490 DOI: https://doi.org/10.5402/2012/292490
Cha S., Whitman G. Glycemic Control Does Matter in the Cardiac Surgery Patient. 5th EAI International Conference, Portugal, 2018. DOI: 10.1007/978-3-030-04146-5_29 DOI: https://doi.org/10.1007/978-3-030-04146-5_29
Boreland L., Scott-Hudson M., Hetherington K., Frussinetty A., Slyer JT. The effectiveness of tight glycemic control on decreasing surgical site infections and readmission rates in adult patients with diabetes undergoing cardiac surgery: A systematic review. Hear Lung. 2015; 44(5): 430–440. DOI: https://doi.org/10.1016/j.hrtlng.2015.06.004
Hulst AH., Plummer MP., Hollmann MW., DeVries JH., Preckel B., Deane AM, Hermanides J. Systematic review of incretin therapy during perioperative and intensive care. Crit Care. 2018; 22(1): 299. DOI: https://doi.org/10.1186/s13054-018-2197-4
Yeldandi RR., Lurie A., Baldwin D. Comparison of once-daily glargine insulin with twice-daily NPH/regular insulin for control of hyperglycemia in inpatients after cardiovascular surgery. Diabetes Technol Ther. 2006; 8(6): 609–616. DOI: https://doi.org/10.1089/dia.2006.8.609
Albacker TB., Carvalho G., Schricker T., Lachapelle K. Myocardial Protection During Elective Coronary Artery Bypass Grafting Using High-Dose Insulin Therapy. Ann Thorac Surg. 2007; 84(6): 1920–1927. DOI: https://doi.org/10.1016/j.athoracsur.2007.07.001
Polderman JAW., van Steen SCJ., Thiel B., Godfried MB., Houweling PL., Hollmann MW., DeVries JH., Preckel B., Hermanides J. Perioperative management of patients with type-2 diabetes mellitus undergoing non-cardiac surgery using liraglutide, glucose-insulin-potassium infusion or intravenous insulin bolus regimens: a randomised controlled trial. Anaesthesia. 2018; 73(3): 332–339. DOI: https://doi.org/10.1111/anae.14180
Hoo GW. Intravenous Insulin Therapy. 2020. Medscape Available online: https://emedicine.medscape.com/article/2049152-overview#a11 (access on 1st of June 2020)
Wilson M., Weinreb J., Hoo GW. Intensive insulin therapy in critical care: a review of 12 protocols. Diabetes Care. 2007; 30(4): 1005-11. doi: 10.2337/dc06-1964. Epub 2007 Jan 9. PMID: 17213376. DOI: https://doi.org/10.2337/dc06-1964
Duggan EW., Carlson K., Umpierrez GE. Perioperative Hyperglycemia Management. Anesthesiology. 2017; 126(3): 547–60. DOI: https://doi.org/10.1097/ALN.0000000000001515
Clinicaltrials.gov. 2021. U.S. National library of Medicine (NIH). Available online https://clinicaltrials.gov/ct2/show/NCT04824586?term=Insulin&cntry=JO&draw=2&rank=1
Gutch M., Kumar S., Razi S., Gupta K., Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab [Internet]. 2015; 19(1): 160. Available from: https://journals.lww.com/10.4103/2230-8210.146874 DOI: https://doi.org/10.4103/2230-8210.146874
Meysamie A., Taee F., Mohammadi-Vajari MA., Yoosefi-Khanghah S., Emamzadeh-Fard S., Abbassi M. Sample size calculation on web, can we rely on the results? J Med Stat Informatics. 2014: 2(1): 3. DOI: https://doi.org/10.7243/2053-7662-2-3
Reeder CE. Overview of pharmacoeconomics and pharmaceutical outcomes evaluations. Am J Health Syst Pharm. 1995; 52(19 Suppl 4), S5-8. DOI: https://doi.org/10.1093/ajhp/52.19_Suppl_4.S5
Ahuja J., Gupta M., Gupta AK., Kohli K. Pharmacoeconomics. Natl Med J India. 2004; 17(2): 80–83.
Elkins M. Concealed allocation in randomised trials. J Physiother. 2013; 59(2): 134–136. DOI: https://doi.org/10.1016/S1836-9553(13)70174-7
Efird J. Blocked Randomization with Randomly Selected Block Sizes. Int J Environ Res Public Health. 2010; 8(1): 15–20. DOI: https://doi.org/10.3390/ijerph8010015
Cosson E., Catargi B., Cheisson G., Jacqueminet S., Ichai C., Leguerrier A., Ouattara A., Tauveron I., Bismuth E., Benhamou P., Valensi P. Position Statement/Recommendations Practical management of diabetes patients before, during and after surgery: A joint French diabetology and anaesthesiology position statement. Diabetes Metab. 2018; 44: 200–216. DOI: https://doi.org/10.1016/j.diabet.2018.01.014
Arun P., Krishna HM. Comparative study between insulin bolus regimen and glucose insulin infusion regimen on effectiveness of intraoperative blood glucose control in patients with type 2 diabetes mellitus undergoing non-cardiac surgery. Sri Lankan J Anaesthesiol. 2019: 27(2): 110. DOI: https://doi.org/10.4038/slja.v27i2.8400
Kruger C., Sidebotham D., Brown AJ., Singh H., Merry AF. Timely bolus insulin for glucose control during cardiopulmonary bypass. J Extra Corpor Technol. 2012; 44(1): 34-38. DOI: https://doi.org/10.1051/ject/201244034
Navaratnarajah M., Rea R., Evans R., Gibson F., Antoniades C., Keiralla A., Demosthenous M., Kassimis G., Krasopoulos G. Effect of glycaemic control on complications following cardiac surgery: literature review. J Cardiothorac Surg. 2018; 13(10). https://doi.org/10.1186/s13019-018-0700-2 DOI: https://doi.org/10.1186/s13019-018-0700-2
Furnary AP., Gao G., Grunkemeier GL., Wu Y., Zerr KJ., Bookin SO., Floten HS., Starr A. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003; 125(5): 1007-21. doi: 10.1067/mtc.2003.181. PMID: 12771873 DOI: https://doi.org/10.1067/mtc.2003.181
