Clinical and Laboratory Parameters Associated With Different Degrees of Dehydration Among Children With Diabetic Ketoacidosis

NCT ID: NCT05383404

Last Updated: 2023-03-31

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

2022-06-25

Study Completion Date

2023-06-30

Brief Summary

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Diabetic ketoacidosis (DKA) is a common acute complication of type 1 diabetes mellitus (T1DM). DKA is characterized by hyperglycemia, metabolic acidosis, increased levels of ketone bodies in blood and urine. This leads to osmotic diuresis and severe depletion of water and electrolytes from both the intra- and extracellular fluid (ECF) compartments.

Estimation of the degree of dehydration for children admitted with DKA is of great clinical importance. The calculation of the amount of deficit therapy depends on the estimated degree of dehydration. However, the degree of dehydration present during DKA is difficult to be clinically assessed. Hyperosmolality tends to preserve intravascular volume with maintenance of peripheral pulses, blood pressure, and urine output until extreme volume depletion occurs. Metabolic acidosis leads to hyperventilation and dry oral mucosa as well as decreased peripheral vascular resistance and cardiac function . consequently, hyper-osmolality may lead to an underestimation of the degree of dehydration, whereas metabolic acidosis may lead to an overestimation of the degree of dehydration. This makes the physical findings unreliable in this setting.

Several clinical and biochemical markers were suggested to assess and stage the degree of dehydration at hospital admission. The blood urea nitrogen , hematocrit , plasma albumin are useful markers of the degree of ECF contraction.However, Several previous studies demonstrated that there was no agreement between assessed and measured degree of dehydration which is calculated according to change in body weight at admission and after correction of dehydration. there were tendencies to overestimated or underestimate the degree of dehydration between different physicians. The assessment of the magnitude of dehydration in DKA is of major interest and continues to be a subject of research.

This study aims to assess the association between different clinical and laboratory parameters in children with diabetic ketoacidosis and the degree of dehydration at hospital admission among those children.

Detailed Description

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Conditions

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Diabetic Ketoacidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mild dehydration

(3-5)% according to change in body weight.

blood and urine samples

Intervention Type DIAGNOSTIC_TEST

complete blood count, blood glucose, blood gases, serum bicarbonates, serum electrolytes, serum albumin ,serum creatinine. blood urea nitrogen, urine analysis.

moderate dehydration

(6-9)% according to change in body weight.

blood and urine samples

Intervention Type DIAGNOSTIC_TEST

complete blood count, blood glucose, blood gases, serum bicarbonates, serum electrolytes, serum albumin ,serum creatinine. blood urea nitrogen, urine analysis.

severe dehydration

(6-9)% according to change in body weight.

blood and urine samples

Intervention Type DIAGNOSTIC_TEST

complete blood count, blood glucose, blood gases, serum bicarbonates, serum electrolytes, serum albumin ,serum creatinine. blood urea nitrogen, urine analysis.

Interventions

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blood and urine samples

complete blood count, blood glucose, blood gases, serum bicarbonates, serum electrolytes, serum albumin ,serum creatinine. blood urea nitrogen, urine analysis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children with T1DM aged 0-12 years admitted to the pediatric emergency department with DKA criteria (blood glucose level \> 200 mg/dl, pH \< 7.3, and /or bicarbonate level in blood \< 15 mmol/l and positive ketones in urine by dipstick method) will be included.

Exclusion Criteria

* Children with DKA who are referred to Sohag university hospital after starting treatment for DKA at another hospital.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Ismail

resident doctor at pediatric department at faculty of medicine sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed A ismail, resident

Role: CONTACT

01009852166

Alzahraa A Ahmed, professor

Role: CONTACT

Facility Contacts

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Osama R Elshrif, professor

Role: primary

References

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Vicinanza A, Messaaoui A, Tenoutasse S, Dorchy H. Diabetic ketoacidosis in children newly diagnosed with type 1 diabetes mellitus: Role of demographic, clinical, and biochemical features along with genetic and immunological markers as risk factors. A 20-year experience in a tertiary Belgian center. Pediatr Diabetes. 2019 Aug;20(5):584-593. doi: 10.1111/pedi.12864. Epub 2019 May 15.

Reference Type BACKGROUND
PMID: 31038262 (View on PubMed)

Raghupathy P. Diabetic ketoacidosis in children and adolescents. Indian J Endocrinol Metab. 2015 Apr;19(Suppl 1):S55-7. doi: 10.4103/2230-8210.155403.

Reference Type BACKGROUND
PMID: 25941653 (View on PubMed)

Ugale J, Mata A, Meert KL, Sarnaik AP. Measured degree of dehydration in children and adolescents with type 1 diabetic ketoacidosis. Pediatr Crit Care Med. 2012 Mar;13(2):e103-7. doi: 10.1097/PCC.0b013e3182231493.

Reference Type BACKGROUND
PMID: 21666534 (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)

Other Identifiers

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Soh-Med-22-05-11

Identifier Type: -

Identifier Source: org_study_id

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