Role of CBC as a Prognostic Marker for DKA Patients

NCT ID: NCT05666895

Last Updated: 2022-12-28

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

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-07-01

Brief Summary

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1. To evaluate that change of platelet-to-lymphocyte Ratio affect the duration of hospital stay and mortality rate of DKA patients
2. To assess the impact of red blood cell distribution width (RDW) on the prognosis of diabetic ketoacidosis patients
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

Detailed Description

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Diabetes Mellitus (DM) is a serious threat to global health with an increasing prevalence and incidence rates,The number of people who had DM was 463 million in 2019,and according to international diabetes federation \[IDF\] this number will have reached 700 million in 2045 (1).

One of the most serious complication of DM is diabetic ketoacidosis (DKA) which is a life-threatening acute copmlication of diabetes mellitus \[DM\], \[DKA\] occur in patients with both type 1 and type 2 diabetes, for which type 1 and type 2 diabetes is responsible for 66% and 34% patients respectively (2,3).

Despite the development of improved treatment, DKA remains at a high incidence of recurrence and a leading cause of mortality among patients with DM, resulting in an elevated burden for patients,hospitals,and healthcare providers(4,5).

As a systemic metabolic disease,DKA has been reported to be associated with the inflammatory response of the hyperglycaemic state(6,7). 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 One of the most things that affected by diabetic ketoacidosis is hydration status, As DKA can cause dehydration and some complications may result from that such as cerebral edema,coma or even death(8,9).

there are many methods to estimate the hydration status such as clinical dehydration scale(CDS), hematological parameters (RBC, Hct , Hb MCV, PLT ,WBC) which are used as an alternative approach to estimate the extent of dehydration in DKA patients(10,11).

Conditions

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Diabetic Ketoacidosis

Keywords

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CBC in DKA Patients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Mamdouh Tawfik Abdelaleem

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine assuit university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed Mamdouh Tawfik abdelaleem

Role: CONTACT

Phone: 01060264431

Email: [email protected]

Hwaida Abdelhakem Nafady, Lecturer

Role: CONTACT

Phone: 0109 472 1339

Email: [email protected]

References

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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)

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.

Reference Type BACKGROUND
PMID: 26266145 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23751904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23757621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19520872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28672172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28222533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29900641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25868190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3928249 (View on PubMed)

Other Identifiers

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CBC in DKA Patients

Identifier Type: -

Identifier Source: org_study_id