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Diabetic KetoacidosisNCT05666895

Role of CBC as a Prognostic Marker for DKA Patients

An observational study of Diabetic Ketoacidosis, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Ketoacidosis
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Jan 2023to 1 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Mohamed Mamdouh Tawfik abdelaleem contact

01060264431

mohamaad81095@gmail.com

Hwaida Abdelhakem Nafady, Lecturer contact

0109 472 1339

howaidanafady@yahoo.com

Egypt1 site

  • Faculty of medicine assuit university

    Asyut

Other trials in Egypt

About this study

  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).

Keywords
CBC in DKA Patients
Medical subject headings
Diabetic Ketoacidosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Secondary outcomes (1)

  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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666895
Sponsor's protocol ID
CBC in DKA Patients
Status last verified
Dec 2022
First submitted
14 Dec 2022
Last updated
28 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Ketoacidosis, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Mamdouh Tawfik abdelaleem (01060264431, mohamaad81095@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05666895, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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