Viewing Study NCT05666895


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Study NCT ID: NCT05666895
Status: UNKNOWN
Last Update Posted: 2022-12-28
First Post: 2022-12-14
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Role of CBC as a Prognostic Marker for DKA Patients
Sponsor: Assiut University
Organization:

Study Overview

Official Title: Role of CBC as a Prognostic Marker for DKA Patients
Status: UNKNOWN
Status Verified Date: 2022-12
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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: 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).

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: