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HyperglycemiaNCT04665128

Management of Hyperglycemic Patients in Emergency Medicine Department

An observational study of Hyperglycemia and Diabetes Mellitus, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperglycemia, Diabetes Mellitus, Emergencies
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2020to 30 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients over the age of 18, presenting to the emergency department.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Nurcihan Ulku Aytas contact

+905394636380

nurcihanaytas@gmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Kocaeli Derince Training and Research Hospital

    Kocaeli, 41390

    Nurcihan Ülkü Aytaş, MD

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed 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.
Medical subject headings
Hyperglycemia, Diabetes Mellitus, Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completion15 Mar 2021 (estimated)
  4. Study completion30 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04665128
Sponsor's protocol ID
2020/147
Status last verified
Dec 2020
First submitted
7 Dec 2020
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27979889

  • 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.

    PubMed 24357215

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

    PubMed 1928997

  • 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.

    PubMed 12960028

  • 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.

    PubMed 11889147

  • 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.

    PubMed 8270125

  • 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.

    PubMed 18635989

  • 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.

    PubMed 14747243

  • 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.

    PubMed 19218025

  • 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.

    PubMed 28646357

  • 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.

    PubMed 26109328

  • 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.

    PubMed 25222424

  • 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.

    PubMed 27353284

  • 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.

    PubMed 28993036

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperglycemia and Diabetes Mellitus, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nurcihan Ulku Aytas (+905394636380, nurcihanaytas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reducing the glucose levels of hyperglycemic patients in the emergency department may improve clinical outcomes and have a positive effect on post-discharge prognosis. (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04665128, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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