Management of Hyperglycemic Patients in Emergency Medicine Department

NCT ID: NCT04665128

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2021-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia Diabetes Mellitus Emergencies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nurcihan Ulku Aytas

Emergency medicine resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kocaeli Derince Training and Research Hospital

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nurcihan Ulku Aytas

Role: CONTACT

Phone: +905394636380

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nurcihan Ülkü Aytaş, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

American Diabetes Association. 2. Classification and Diagnosis of Diabetes. Diabetes Care. 2017 Jan;40(Suppl 1):S11-S24. doi: 10.2337/dc17-S005. No abstract available.

Reference Type BACKGROUND
PMID: 27979889 (View on PubMed)

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.

Reference Type BACKGROUND
PMID: 24357215 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1928997 (View on PubMed)

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. doi: 10.1210/en.2003-0697. Epub 2003 Aug 28.

Reference Type BACKGROUND
PMID: 12960028 (View on PubMed)

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. doi: 10.1210/jcem.87.3.8341.

Reference Type BACKGROUND
PMID: 11889147 (View on PubMed)

Ceriello A. Coagulation activation in diabetes mellitus: the role of hyperglycaemia and therapeutic prospects. Diabetologia. 1993 Nov;36(11):1119-25. doi: 10.1007/BF00401055.

Reference Type BACKGROUND
PMID: 8270125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18635989 (View on PubMed)

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. doi: 10.2337/diacare.27.2.553. No abstract available.

Reference Type BACKGROUND
PMID: 14747243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19218025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28646357 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26109328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25222424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27353284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28993036 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/147

Identifier Type: -

Identifier Source: org_study_id