Diabetic KetoacidosisNCT05383404
Clinical and Laboratory Parameters Associated With Different Degrees of Dehydration Among Children With Diabetic Ketoacidosis
An observational study of Diabetic Ketoacidosis, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 hour to 12 years
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- blood and urine samples
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2022to Jun 2023
- 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 1 hour to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Children with DKA who are referred to Sohag university hospital after starting treatment for DKA at another hospital.
Trial locations and contacts
1 site in 1 country.
Alzahraa A Ahmed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R Elshrif, professor
About this study
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.
Read more
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.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- blood and urine samples
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and urine samplesDiagnostic test
complete blood count, blood glucose, blood gases, serum bicarbonates, serum electrolytes, serum albumin ,serum creatinine. blood urea nitrogen, urine analysis.
| Study group | Role | What they receive |
|---|---|---|
| mild dehydration | (3-5)% according to change in body weight. Receives: Diagnostic Test: blood and urine samples | |
| moderate dehydration | (6-9)% according to change in body weight. Receives: Diagnostic Test: blood and urine samples | |
| severe dehydration | (6-9)% according to change in body weight. Receives: Diagnostic Test: blood and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
measured degree of dehydration
calculated as percentage of the difference between the weight at disharge from Picu and the weight at admission to the weight at disharge from Picu
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start25 Jun 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ismail, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383404
- Sponsor's protocol ID
- Soh-Med-22-05-11
- Status last verified
- Mar 2023
- First submitted
- 16 May 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31038262Raghupathy P. Diabetic ketoacidosis in children and adolescents. Indian J Endocrinol Metab. 2015 Apr;19(Suppl 1):S55-7. doi: 10.4103/2230-8210.155403.
PubMed 25941653Ugale 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.
PubMed 21666534Wolfsdorf 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Parameters Associated With Different Degrees of Dehydration Among Children With Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT05383404
- Acronym / sponsor ID
- Soh-Med-22-05-11
- Conditions
- Diabetic Ketoacidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild dehydration | – | Diagnostic Test: blood and urine samples(3-5)% according to change in body weight. |
| moderate dehydration | – | Diagnostic Test: blood and urine samples(6-9)% according to change in body weight. |
| severe dehydration | – | Diagnostic Test: blood and urine samples(6-9)% according to change in body weight. |
Who may qualify
- Ages
- 1 hour to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with DKA who are referred to Sohag university hospital after starting treatment for DKA at another hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and urine samplescomplete blood count, blood glucose, blood gases, serum bicarbonates, serum electrolytes, serum albumin ,serum creatinine. blood urea nitrogen, urine analysis. | Diagnostic test | mild dehydration, moderate dehydration, severe dehydration |
Primary outcome
measured degree of dehydration
Time frame: 1year
calculated as percentage of the difference between the weight at disharge from Picu and the weight at admission to the weight at disharge from Picu
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 31038262Vicinanza 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.
- Background: PubMed 25941653Raghupathy P. Diabetic ketoacidosis in children and adolescents. Indian J Endocrinol Metab. 2015 Apr;19(Suppl 1):S55-7. doi: 10.4103/2230-8210.155403.
- Background: PubMed 21666534Ugale 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.
- Background: PubMed 29900641Wolfsdorf 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alzahraa A Ahmed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis, run by Sohag 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 31 Mar 2023. 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 A ismail, resident (01009852166, mohammad.esmaeel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measured degree of dehydration (time frame: 1year). 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 NCT05383404, which also lists 4 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 31 Mar 2023.