Pediatric DisorderNCT03454152
Ecg & Echo Changes in Children With DKA
An observational study of Pediatric Disorder, run by Assiut University.
Trial summary
Diabetic ketoacidosis (DKA) is an important complication of childhood diabetes mellitus and the most frequent diabetes-related cause of death in children. Diabetic ketoacidosis (DKA) is caused by a decrease in effective circulating insulin associated with increases in counter regulatory hormones including glucagon… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Disorder
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Jun 2020
- How long will I take part?
- 1 Day
- 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 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All pediatric patients with diabetic ketoacidosis come to Assuit University Children Hospital within one year.
Who may be able to join
- Pediatric patients aged : 1 month -18years with diabetic ketoacidosis
Who cannot join
- Pediatric Patients who have associated cardiovascular disease. ( congenital or rheumatic).
- Pediatric patients with hyperglycemic hyperosmolar state.
- Pediatric patients with other causes of metabolic acidosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Electrocardiogram and Echocardiography Changes in Children With Diabetic Ketoacidosis
Diabetic ketoacidosis (DKA) is an important complication of childhood diabetes mellitus and the most frequent diabetes-related cause of death in children.
Diabetic ketoacidosis (DKA) is caused by a decrease in effective circulating insulin associated with increases in counter regulatory hormones including glucagon, catecholamines, cortisol, and growth hormone. This leads to increased glucose production by the liver and kidney and impaired peripheral glucose utilisation with resultant hyperglycaemia, and hyperosmolality. Increased lipolysis, with ketone body (beta-hydroxybutyrate, acetoacetate) production causes ketonaemia and metabolic acidosis. Hyperglycaemia and acidosis result in osmotic diuresis, dehydration, and obligate loss of electrolytes.
Read the detailed description
DKA can affect cardiovascular function through several mechanisms. The effect of acidosis on the heart depends upon the pH level. In mild acidosis, there is increased catecholamine release which is compensated by increased inotropy, chronotropy, cardiac output and peripheral vascular resistance. When acidosis is severe, i.e. pH is less than 7.2, the H+ ions have a direct cardiac depressant action.
Fluid and electrolyte imbalance is very common in DKA, Potassium deficit is one of the most important of electrolyte imbalances seen in DKA as it can lead to fatal arrhythmias. The most common and perhaps the earliest ECG finding in hypokalemia is a prominent U wave, usually evident in leads II and III. The most common cardiac arrhythmias are atrial premature contractions, atrial tachycardia with or without atrioventricular block, supraventricular and ventricular premature contractions.
- Conditions
- Pediatric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | pediatric patients with diabetic ketoacidosis come to Assuit University Children Hospital within one year. Electrocardiogram and echocardiography will be done to all patient with diabetic ketoacidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography parameters
Right and left ventricular dimension during diabetic ketoacidosis and after correction.
Measured: baseline
Electrocardiogram parameters
QT interval and PR interval.
Measured: baseline
Secondary outcomes (2)
Electrocardiogram changes
ST segment elevation or depression
Measured: baseline
Echocardiography findings
Systolic and diastolic left ventricular function
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study startMar 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (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 Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Younis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454152
- Sponsor's protocol ID
- DKA2018
- Status last verified
- Mar 2018
- First submitted
- 18 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Edge JA, Ford-Adams ME, Dunger DB. Causes of death in children with insulin dependent diabetes 1990-96. Arch Dis Child. 1999 Oct;81(4):318-23. doi: 10.1136/adc.81.4.318.
PubMed 10490436Dunger DB, Sperling MA, Acerini CL, Bohn DJ, Daneman D, Danne TP, Glaser NS, Hanas R, Hintz RL, Levitsky LL, Savage MO, Tasker RC, Wolfsdorf JI; ESPE; LWPES. ESPE/LWPES consensus statement on diabetic ketoacidosis in children and adolescents. Arch Dis Child. 2004 Feb;89(2):188-94. doi: 10.1136/adc.2003.044875.
PubMed 14736641Gandhi MJ, Suvarna TT. Cardiovascular complications in diabetic ketoacidosis. Int J Diab Dev Countries. 1995;15:132-133.
Chung EK. Electrolyte imbalance and cardiac arrhythmias. In : Principles of Cardiac Arrhythmias. Edward Chung (ed.) Williams and Wilkins, 1989.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiogram and Echocardiography Changes in Children With Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT03454152
- Acronym / sponsor ID
- DKA2018
- Conditions
- Pediatric Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 5 Mar 2018 (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 an important complication of childhood diabetes mellitus and the most frequent diabetes-related cause of death in children.
Diabetic ketoacidosis (DKA) is caused by a decrease in effective circulating insulin associated with increases in counter regulatory hormones including glucagon, catecholamines, cortisol, and growth hormone. This leads to increased glucose production by the liver and kidney and impaired peripheral glucose utilisation with resultant hyperglycaemia, and hyperosmolality. Increased lipolysis, with ketone body (beta-hydroxybutyrate, acetoacetate) production causes ketonaemia and metabolic acidosis. Hyperglycaemia and acidosis result in osmotic diuresis, dehydration, and obligate loss of electrolytes.
Detailed description
DKA can affect cardiovascular function through several mechanisms. The effect of acidosis on the heart depends upon the pH level. In mild acidosis, there is increased catecholamine release which is compensated by increased inotropy, chronotropy, cardiac output and peripheral vascular resistance. When acidosis is severe, i.e. pH is less than 7.2, the H+ ions have a direct cardiac depressant action.
Fluid and electrolyte imbalance is very common in DKA, Potassium deficit is one of the most important of electrolyte imbalances seen in DKA as it can lead to fatal arrhythmias. The most common and perhaps the earliest ECG finding in hypokalemia is a prominent U wave, usually evident in leads II and III. The most common cardiac arrhythmias are atrial premature contractions, atrial tachycardia with or without atrioventricular block, supraventricular and ventricular premature contractions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | –pediatric patients with diabetic ketoacidosis come to Assuit University Children Hospital within one year. Electrocardiogram and echocardiography will be done to all patient with diabetic ketoacidosis |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pediatric patients with diabetic ketoacidosis come to Assuit University Children Hospital within one year.
Key inclusion criteria (1 listed)
- Pediatric patients aged : 1 month -18years with diabetic ketoacidosis
Key exclusion criteria (3 listed)
- Pediatric Patients who have associated cardiovascular disease. ( congenital or rheumatic).
- Pediatric patients with hyperglycemic hyperosmolar state.
- Pediatric patients with other causes of metabolic acidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Echocardiography parameters
Time frame: baseline
Right and left ventricular dimension during diabetic ketoacidosis and after correction.
Electrocardiogram parameters
Time frame: baseline
QT interval and PR interval.
2 secondary outcomes
Electrocardiogram changes
Time frame: baseline
Echocardiography findings
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Background: PubMed 10490436Edge JA, Ford-Adams ME, Dunger DB. Causes of death in children with insulin dependent diabetes 1990-96. Arch Dis Child. 1999 Oct;81(4):318-23. doi: 10.1136/adc.81.4.318.
- Background: PubMed 14736641Dunger DB, Sperling MA, Acerini CL, Bohn DJ, Daneman D, Danne TP, Glaser NS, Hanas R, Hintz RL, Levitsky LL, Savage MO, Tasker RC, Wolfsdorf JI; ESPE; LWPES. ESPE/LWPES consensus statement on diabetic ketoacidosis in children and adolescents. Arch Dis Child. 2004 Feb;89(2):188-94. doi: 10.1136/adc.2003.044875.
- BackgroundGandhi MJ, Suvarna TT. Cardiovascular complications in diabetic ketoacidosis. Int J Diab Dev Countries. 1995;15:132-133.
- BackgroundChung EK. Electrolyte imbalance and cardiac arrhythmias. In : Principles of Cardiac Arrhythmias. Edward Chung (ed.) Williams and Wilkins, 1989.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatric Disorder
RecruitingObservational study
Menin Inhibitors in Pediatric Relapsed or Refractory Acute Leukemia
Acute Leukemia, Relapsed or Refractory Pediatric Leukemia
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Disorder, run by Assiut University.
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 3 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 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Hanaa Mohammad, prof (01064747613, hae50@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiography parameters (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT03454152, 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 5 Mar 2018.