Management of Hyperglycemic Patients in Emergency Medicine Department

Diabetes Mellitus Clinical Trial

Official title:

Determining the Factors That Affects Emergency Department Visits of Hyperglycemic Patients in 30 Days.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665128
• Other study ID #: 2020/147
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: December 2020
• Source: Derince Training and Research Hospital
• Contact: Nurcihan Ulku Aytas
• Phone: +905394636380
• Email: nurcihanaytas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main purpose of this study is how to manage hyperglycemic patients in emergency departments, to determine the conditions that require blood glucose regulation and to examine the prognosis of the patients in the next 30 days, depending on the regulation method.

Description:

The study will be conducted between 15.12.2020 and 15.03.2021. Patients over the age of 18 who applied to the emergency department with any complaint and whose blood glucose level> 300 mg / dl in the examinations (as the finger tip and / or blood biochemistry examination parameter) performed in case of clinical necessity will be included in the study. Patients or their relatives (for patients who are unable to give consent) will be asked to read and sign the informed consent form if they accept it. Patients' age, gender, history, whether they are diagnosed with diabetes, medications used, vital signs, complaints of admission to the emergency room, hospitalization and definitive diagnosis will be recorded. The study form for the followed-up patients will be added to each patient's file and filled in by the physicians in the patient's follow-up.

The following parameters will be included in the work form;

1. Age of the patient

2. Gender

3. Biography

4. Presence of diabetes diagnosis, drugs used, if any

5. Other medications

6. The complaint of applying to the emergency room

7. Whether treatment for hyperglycemia is applied in the emergency department, what treatment is applied

8. How much IV fluid and / or insulin therapy is applied

9. Duration of stay in the emergency department

10. Results of routine blood tests

11. Weight

12. The trend of blood glucose levels in patients treated for hyperglycemia

13. Presence of acute complications due to hyperglycemia

14. Application and discharge BG levels

15. Whether there are classical symptoms of DM before admission to the emergency department

16. Whether hypoglycemia develops or not

17. Was medication prescribed for DM at the time of discharge?

18. Whether he was hospitalized or not. Patients will be called 30 days after leaving the emergency room (ER). Within this period, whether they applied to the emergency service again, if they did, the application complaint, the diagnosis of ER discharge, and the treatment method used will be questioned.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over the age of 18, presenting to the emergency department with any complaint and with a glucose level> 300 mg / dL in blood tests will be included in the study.

Exclusion Criteria:

• Pregnant, under 18 years of age, patients who were referred to the emergency department by referral from another center, patients who received intravenous glucose treatment, patients using systemic glucocorticoids, hepatic insufficiency, renal failure, adrenal insufficiency, pancreatitis, metastatic carcinoma, patients receiving chemotherapy, patients with instability criteria will not be taken into work.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Emergencies
• Hyperglycemia

Locations

Country	Name	City	State
Turkey	Kocaeli Derince Training and Research Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

American Diabetes Association. 2. Classification and Diagnosis of Diabetes. Diabetes Care. 2017 Jan;40(Suppl 1):S11-S24. Review. — View Citation

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. — View Citation

Ceriello A. Coagulation activation in diabetes mellitus: the role of hyperglycaemia and therapeutic prospects. Diabetologia. 1993 Nov;36(11):1119-25. Review. — View Citation

Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. Review. Erratum in: Diabetes Care. 2004 Mar;27(3):856. Hirsh, Irl B [corrected to Hirsch, Irl B]. Diabetes Care. 2004 May;27(5):1255. — View Citation

Driver BE, Olives TD, Bischof JE, Salmen MR, Miner JR. Discharge Glucose Is Not Associated With Short-Term Adverse Outcomes in Emergency Department Patients With Moderate to Severe Hyperglycemia. Ann Emerg Med. 2016 Dec;68(6):697-705.e3. doi: 10.1016/j.annemergmed.2016.04.057. Epub 2016 Jun 25. — View Citation

Driver BE, Olives TD, Prekker ME, Miner JR, Klein LR. The Association of Emergency Department Treatments for Hyperglycemia with Glucose Reduction and Emergency Department Length of Stay. J Emerg Med. 2017 Dec;53(6):791-797. doi: 10.1016/j.jemermed.2017.08.068. Epub 2017 Oct 6. — View Citation

Echouffo-Tcheugui JB, Garg R. Management of Hyperglycemia and Diabetes in the Emergency Department. Curr Diab Rep. 2017 Aug;17(8):56. doi: 10.1007/s11892-017-0883-2. Review. — View Citation

Fietsam R Jr, Bassett J, Glover JL. Complications of coronary artery surgery in diabetic patients. Am Surg. 1991 Sep;57(9):551-7. — View Citation

Gentile NT, Siren K. Glycemic control and the injured brain. Emerg Med Clin North Am. 2009 Feb;27(1):151-69, x. doi: 10.1016/j.emc.2008.08.010. Review. — View Citation

Martin WG, Galligan J, Simpson S Jr, Greenaway T, Burgess J. Admission blood glucose predicts mortality and length of stay in patients admitted through the emergency department. Intern Med J. 2015 Sep;45(9):916-24. doi: 10.1111/imj.12841. — View Citation

Patel KL. Impact of tight glucose control on postoperative infection rates and wound healing in cardiac surgery patients. J Wound Ostomy Continence Nurs. 2008 Jul-Aug;35(4):397-404; quiz 405-6. doi: 10.1097/01.WON.0000326659.47637.d0. — View Citation

Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. — View Citation

Weekers F, Giulietti AP, Michalaki M, Coopmans W, Van Herck E, Mathieu C, Van den Berghe G. Metabolic, endocrine, and immune effects of stress hyperglycemia in a rabbit model of prolonged critical illness. Endocrinology. 2003 Dec;144(12):5329-38. Epub 2003 Aug 28. — View Citation

Zelihic E, Poneleit B, Siegmund T, Haller B, Sayk F, Dodt C. Hyperglycemia in emergency patients--prevalence and consequences: results of the GLUCEMERGE analysis. Eur J Emerg Med. 2015 Jun;22(3):181-7. doi: 10.1097/MEJ.0000000000000199. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing the glucose levels of hyperglycemic patients in the emergency department may improve clinical outcomes and have a positive effect on post-discharge prognosis.	The main purpose of this study is to determine how to manage hyperglycemic patients in emergency departments, to determine the conditions that require blood glucose regulation and to examine the prognosis of the patients in the next 30 days, depending on the regulation method.	48 hours