Efficacy and safety of two protocols of intravenous insulin therapy in the management of diabetic ketoacidosis

##plugins.themes.academic_pro.article.main##

Sarra Jouini
Safia Othmani
Asma Aloui
Kehna Bouzid
Hela Manai
Hana Hedhli

Abstract

Introduction: The correction of insulin deficiency in ketoacidosis DKA is recommended by intravenous (IV) route. Despite abundant literature,
the place of the initial bolus of insulin has remained controversial.

Aims: This study was designed to compare the safety and the efficacy of two protocols of intravenous (IV) insulin therapy in the management
of DKA admitted in the emergency department.
Protocol (A): IV bolus of regular insulin 0.10 UI/Kg followed by a continuous IV infusion of insulin 0.10 UI/kg/H.
Protocol (B): No bolus, a continuous IV infusion of regular insulin 0.14 UI/kg/H.
Methods: This was a prospective, not blinded, randomized study including patients aged more than 16 years with moderate to severe DKA.
Fluid therapy and potassium replacement were standardized. Patients were randomized into two groups: Bolus-maintenance 0.10 group
received protocol (A) and Maintenance 0.14 group received protocol (B). The Primary outcome data was the time to recovery defined by the
time to acidosis resolution. The safety was tested by the occurrence of complications: hypoglycemia and hypokalemia.
Results: We enrolled 129 consecutive DKA patients. There were no differences between the two groups in clinical and biochemical data on
admission, Bolus-maintenance 0.10 group versus Maintenance 0.14 group: mean age (37±18 vs. 38±17 years; p=0.810), Type 1 diabetes n
(%): 34(55.7) vs. 34(50); p=0.911, pH (7.14±0.13 vs. 7.15±0.12; p=0.43). There were no differences between the two groups in the outcomes
data: Bolus-maintenance 0.10 group versus Maintenance 0.14 group: Time to recovery (17 vs. 16 hours; p=0.76), complication n (%):
Hypoglycemia (7(11.5) vs. 10(15.9); p=0.57) and hypokalemia (32(56.1) vs. 30(46.9); p=0.30).

Conclusion: In the treatment of diabetic ketoacidosis, the two protocols of IV insulin were safe and had a comparable efficiency.

Keywords:

Diabetic ketoacidosis, insulin, intravenous bolus, emergency department.

##plugins.themes.academic_pro.article.details##

References

  1. Nyenwe EA, Kitabchi AE. Evidence-based management of hyperglycemic emergencies in diabetes mellitus. Diabetes Res Clin Pract. 2011;94(3):340-51.
  2. Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014;103(2):137-49.
  3. Fayfman M, Pasquel FJ, Umpierrez GE. Management of Hyperglycemic Crises: Diabetic Ketoacidosis and Hyperglycemic Hyperosmolar State. Med Clin North Am. 2017;101(3):587-606.
  4. Azevedo LC, Choi H, Simmonds K, Davidow J, Bagshaw SM. Incidence and long-term outcomes of critically ill adult patients with moderate-to-severe diabetic ketoacidosis: retrospective matched cohort study. J Crit Care. 2014;29(6):971-7.
  5. Kitabchi AE, Umpierrez GE, Miles JM, Fisher JN. Hyperglycemic crises in adult patients with diabetes. Diabetes care. 2009;32(7):1335-43.
  6. Esra K F, Amy C D, Mary T K. Diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome: review of acute decompensated diabetes in adult patients. BMJ 2019;365:l1114. doi: 10.1136/bmj.l1114.
  7. Kitabchi AE, Umpierrez GE, Murphy MB, Kreisberg RA. Hyperglycemic crises in adult patients with diabetes: a consensus statement from the American Diabetes Association. Diabetes care. 2006;29(12):2739-48.
  8. Sarra J, Fatma H, Rym H, Hana H, Hela M, Ines C, and al. Utility of bolus of insulin in diabetic ketoacidosis management in emergency department. J Anest Inten Care Med.2019;8(5):555749. DOI: http://dx.doi.org/10.19080/ JAICM.2019.08.555749.
  9. Rabinowitch IM. Diabetic coma and diabetic mortality rates. CMAJ. 1929;21(5):583-6.
  10. Clements RS, Jr., Vourganti B. Fatal diabetic ketoacidosis: major causes and approaches to their prevention. Diabetes care. 1978;1(5):314-25.
  11. Felig P. Diabetic ketoacidosis. NEJM. 1974;290(24):1360-3.
  12. Wagner A, Risse A, Brill HL, Wienhausen-Wilke V, Rottmann M, Sondern K, et al. Therapy of severe diabetic ketoacidosis. Zeromortality under very-low-dose insulin application. Diabetes care. 1999;22(5):674-7.
  13. Graves EJ, Gillum BS. Detailed diagnoses and procedures, National Hospital Discharge Survey, 1995. Vital and health statistics Series 13, Data from the National Health Survey. 1997(130):1-146.
  14. Kitabchi AE, Ayyagari V, Guerra SM. The efficacy of low-dose versus conventional therapy of insulin for treatment of diabetic ketoacidosis. Ann Intern Med. 1976;84(6):633-8.
  15. Fisher JN, Shahshahani MN, Kitabchi AE. Diabetic ketoacidosis: low-dose insulin therapy by various routes. NEJM. 1977;297(5):238-41.
  16. Kitabchi AE, Murphy MB, Spencer J, Matteri R, Karas J. Is a Priming Dose of Insulin Necessary in a Low-Dose Insulin Protocol for the Treatment of Diabetic Ketoacidosis? Diabetes Care 2008;31(11):2081 5.
  17. Kitabchi AE, Umpierrez GE, Fisher JN, Murphy MB, Stentz FB. Thirty Years of Personal Experience in Hyperglycemic Crises: Diabetic Ketoacidosis and Hyperglycemic Hyperosmolar State. J Clin Endocrinol Metab 2008;93(5):1541 52
  18. Barrett EJ, DeFronzo RA, Bevilacqua S, Ferrannini E. Insulin resistance in diabetic ketoacidosis. Diabetes. 1982;31(10):923-8.
  19. Ginsberg HN. Investigation of insulin resistance during diabetic ketoacidosis: role of counterregulatory substances and effect of insulin therapy. Metab.Clin.Exp. 1977;26(10):1135-46.
  20. Goyal N, Miller JB, Sankey SS, Mossallam U. Utility of initial bolus insulin in the treatment of diabetic ketoacidosis. J Emerg Med. 2010;38(4):422-7.
  21. Wolfsdorf JI. The International Society of Pediatric and Adolescent Diabetes guidelines for management of diabetic ketoacidosis: Do the guidelines need to be modified? Pediatr Diabetes. 2014;15(4):277-86.
  22. Hsia E, Seggelke S, Gibbs J, Hawkins RM, Cohlmia E, Rasouli N, et al. Subcutaneous administration of glargine to diabetic patients receiving insulin infusion prevents rebound hyperglycemia. J Clin Endocrinol Metab. 2012;97(9):3132-7.
  23. Umpierrez GE, Latif K, Stoever J, Cuervo R, Park L, Freire AX, et al. Efficacy of subcutaneous insulin lispro versus continuous intravenous regular insulin for the treatment of patients with diabetic ketoacidosis. Am J Med. 2004;117(5):291-6.
  24. tabchi AE, Umpierrez GE, Murphy MB, Barrett EJ, Kreisberg RA, Malone JI, et al. Management of hyperglycemic crises in patients with diabetes. Diabetes care. 2001;24(1):131-53.
  25. Kitabchi AE, Nyenwe EA. Hyperglycemic crises in diabetes mellitus: diabetic ketoacidosis and hyperglycemic hyperosmolar state. Endocrinol Metab clin North Am. 2006;35(4):725-51.