Role of CBC as a Prognostic Marker for DKA Patients

NCT05666895 | Unknown

• 1 other identifier: CBC in DKA Patients
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate that change of platelet-to-lymphocyte Ratio affect the duration of hospital stay and mortality rate of DKA patients
2. 2.To assess the impact of red blood cell distribution width (RDW) on the prognosis of diabetic ketoacidosis patients
3. 3.To evaluate the changes in hematological parameters (RBCs,Hct,Hb,MCV,PLT,WBCs) and their correlations with acidosis level and dehydration during ketoacidosis treatment

Conditions

Diabetic Ketoacidosis

Keywords

CBC in DKA Patients

Outcome Measures

Primary Outcomes (1)

• Measure of inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) changes in DKA patients and affection of these changes on inflammation development and prognosis of DKA

  the inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) play an important role in the development of inflammation and affect prognosis of DKA and and changes in these markers also affect duration of hospital stay and mortality rate in DKA patients

  Baseline

Secondary Outcomes (1)

• Hematological parameters (RBC, Hct , Hb MCV, PLT ,WBC) which are used as an alternative approach to estimate the extent of dehydration in DKA patients

  Baseline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients admitted at ICU at internal medicine departement from 1/2023 to 6/2024 2. Complete history and through clinical examination and investigations at admission and discharge

You may qualify if:

• The study will include patient with type 1 or type 2 DM, patients \> 18 yrs, DKA patients (based on the criteria of the American Diabetes Association (ADA): plasma glucose \> 13.9 mmol/l (250 mg/dL), arterial pH \< 7.3 and a bicarbonate level \<18 mEq/l, with ketonuria)

You may not qualify if:

• The study will exclude patients \<18 yrs , patients with history of hematological disease like(leukemia,hemophilia,thalassemia,sickle cell anaemia,polycythemia vera),patients with history of renal or cardiac or hepatic disease)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine assuit university

Asyut, Egypt

Location

Related Publications (10)

• 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: 24357215 BACKGROUND

• Seth P, Kaur H, Kaur M. Clinical Profile of Diabetic Ketoacidosis: A Prospective Study in a Tertiary Care Hospital. J Clin Diagn Res. 2015 Jun;9(6):OC01-4. doi: 10.7860/JCDR/2015/8586.5995. Epub 2015 Jun 1.

  PMID: 26266145 BACKGROUND

• Misra S, Oliver N, Dornhorst A. Diabetic ketoacidosis: not always due to type 1 diabetes. BMJ. 2013 Jun 10;346:f3501. doi: 10.1136/bmj.f3501. No abstract available.

  PMID: 23751904 BACKGROUND

• Lohiya S, Kreisberg R, Lohiya V. Recurrent diabetic ketoacidosis in two community teaching hospitals. Endocr Pract. 2013 Sep-Oct;19(5):829-33. doi: 10.4158/EP13057.RA.

  PMID: 23757621 BACKGROUND

• Zargar AH, Wani AI, Masoodi SR, Bashir MI, Laway BA, Gupta VK, Wani FA. Causes of mortality in diabetes mellitus: data from a tertiary teaching hospital in India. Postgrad Med J. 2009 May;85(1003):227-32. doi: 10.1136/pgmj.2008.067975.

  PMID: 19520872 BACKGROUND

• Xu L, Wang L, Huang X, Liu L, Ke W, He X, Huang Z, Liu J, Wan X, Cao X, Li Y. Baseline red blood cell distribution width predicts long-term glycemic remission in patients with type 2 diabetes. Diabetes Res Clin Pract. 2017 Sep;131:33-41. doi: 10.1016/j.diabres.2017.06.019. Epub 2017 Jun 15.

  PMID: 28672172 BACKGROUND

• Li W, Huang E, Gao S. Type 1 Diabetes Mellitus and Cognitive Impairments: A Systematic Review. J Alzheimers Dis. 2017;57(1):29-36. doi: 10.3233/JAD-161250.

  PMID: 28222533 BACKGROUND

• Wolfsdorf JI, Glaser N, Agus M, Fritsch M, Hanas R, Rewers A, Sperling MA, Codner E. ISPAD Clinical Practice Consensus Guidelines 2018: Diabetic ketoacidosis and the hyperglycemic hyperosmolar state. Pediatr Diabetes. 2018 Oct;19 Suppl 27:155-177. doi: 10.1111/pedi.12701. No abstract available.

  PMID: 29900641 BACKGROUND

• Bruck E. Laboratory tests in the analysis of states of dehydration. Pediatr Clin North Am. 1971 Feb;18(1):265-83. doi: 10.1016/s0031-3955(16)32538-x.

  PMID: 25868190 BACKGROUND

• Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

  PMID: 3928249 BACKGROUND

MeSH Terms

Conditions

Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Mohamed Mamdouh Tawfik abdelaleem

CONTACT

01060264431; mohamaad81095@gmail.com

Hwaida Abdelhakem Nafady, Lecturer

CONTACT

0109 472 1339; howaidanafady@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 28, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

EG (1)