CClinicalTrials.gg
Status unknownNCT05666895Updated Dec 28, 2022

Role of CBC as a Prognostic Marker for DKA Patients

An observational study in Diabetic Ketoacidosis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Study 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
Read the 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).

02

Conditions studied

  • Diabetic Ketoacidosis

Keywords

  • CBC in DKA Patients
03

In context

Ketosis

181 studies on the registry are indexed under Ketosis; 37 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 31 observational studies indexed under Ketosis.

Browse Ketosis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

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

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)
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

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

    Time frame: 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

    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

    Time frame: Baseline

07

Study locations

1 site
  • Faculty of medicine assuit university
    Assiut, Egypt
08

References and documents

Publications

  • 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 ↗
  • 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. PubMed 26266145 ↗
  • 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. PubMed 23751904 ↗
  • 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. PubMed 23757621 ↗
  • 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. PubMed 19520872 ↗
  • 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. PubMed 28672172 ↗
  • 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. PubMed 28222533 ↗
  • 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. PubMed 29900641 ↗
  • 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. PubMed 25868190 ↗
  • 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. PubMed 3928249 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05666895
Lead sponsor
Assiut University
Responsible party
Mohamed Mamdouh Tawfik Abdelaleem (Resident, Assiut University) — Principal investigator
First posted
Dec 28, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Dec 28, 2022

Study contacts

Mohamed Mamdouh Tawfik abdelaleem
Contact
mohamaad81095@gmail.com
01060264431
Hwaida Abdelhakem Nafady, Lecturer
Contact
howaidanafady@yahoo.com
0109 472 1339

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion