Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 12:06 PM
Study NCT ID:
NCT04665128
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Hyperglycemic Patients in Emergency Medicine Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '48 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperglycemia', 'Diabetes Mellitus', 'Emergencies']}, 'referencesModule': {'references': [{'pmid': '27979889', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24357215', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1928997', 'type': 'BACKGROUND', 'citation': 'Fietsam R Jr, Bassett J, Glover JL. Complications of coronary artery surgery in diabetic patients. Am Surg. 1991 Sep;57(9):551-7.'}, {'pmid': '12960028', 'type': 'BACKGROUND', '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. doi: 10.1210/en.2003-0697. Epub 2003 Aug 28.'}, {'pmid': '11889147', 'type': 'BACKGROUND', '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. doi: 10.1210/jcem.87.3.8341.'}, {'pmid': '8270125', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18635989', 'type': 'BACKGROUND', '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.'}, {'pmid': '14747243', 'type': 'BACKGROUND', '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. doi: 10.2337/diacare.27.2.553. No abstract available.'}, {'pmid': '19218025', 'type': 'BACKGROUND', '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.'}, {'pmid': '28646357', 'type': 'BACKGROUND', '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.'}, {'pmid': '26109328', 'type': 'BACKGROUND', '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.'}, {'pmid': '25222424', 'type': 'BACKGROUND', '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.'}, {'pmid': '27353284', 'type': 'BACKGROUND', '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.'}, {'pmid': '28993036', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe following parameters will be included in the work form;\n\n1. Age of the patient\n2. Gender\n3. Biography\n4. Presence of diabetes diagnosis, drugs used, if any\n5. Other medications\n6. The complaint of applying to the emergency room\n7. Whether treatment for hyperglycemia is applied in the emergency department, what treatment is applied\n8. How much IV fluid and / or insulin therapy is applied\n9. Duration of stay in the emergency department\n10. Results of routine blood tests\n11. Weight\n12. The trend of blood glucose levels in patients treated for hyperglycemia\n13. Presence of acute complications due to hyperglycemia\n14. Application and discharge BG levels\n15. Whether there are classical symptoms of DM before admission to the emergency department\n16. Whether hypoglycemia develops or not\n17. Was medication prescribed for DM at the time of discharge?\n18. 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over the age of 18, presenting to the emergency department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT04665128', 'briefTitle': 'Management of Hyperglycemic Patients in Emergency Medicine Department', 'organization': {'class': 'OTHER', 'fullName': 'Derince Training and Research Hospital'}, 'officialTitle': 'Determining the Factors That Affects Emergency Department Visits of Hyperglycemic Patients in 30 Days.', 'orgStudyIdInfo': {'id': '2020/147'}}, 'contactsLocationsModule': {'locations': [{'zip': '41390', 'city': 'Kocaeli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nurcihan Ülkü Aytaş, MD', 'role': 'CONTACT'}], 'facility': 'Kocaeli Derince Training and Research Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'centralContacts': [{'name': 'Nurcihan Ulku Aytas', 'role': 'CONTACT', 'email': 'nurcihanaytas@gmail.com', 'phone': '+905394636380'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derince Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency medicine resident', 'investigatorFullName': 'Nurcihan Ulku Aytas', 'investigatorAffiliation': 'Derince Training and Research Hospital'}}}}