CClinicalTrials.gg
Status unknownNCT03454152Updated Mar 5, 2018

Ecg & Echo Changes in Children With DKA

An observational study in Pediatric Disorder, sponsored by Assiut University. Status unknown. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
1 Month to 18 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Pediatric Disorder
03

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All pediatric patients with diabetic ketoacidosis come to Assuit University Children Hospital within one year.

Inclusion criteria

  • Pediatric patients aged : 1 month -18years with diabetic ketoacidosis

Exclusion criteria

Exclusion Criteria:

  • Pediatric Patients who have associated cardiovascular disease. ( congenital or rheumatic).
  • Pediatric patients with hyperglycemic hyperosmolar state.
  • Pediatric patients with other causes of metabolic acidosis.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

  1. Echocardiography parameters

    Right and left ventricular dimension during diabetic ketoacidosis and after correction.

    Time frame: baseline

  2. Electrocardiogram parameters

    QT interval and PR interval.

    Time frame: baseline

Secondary outcomes

  1. Electrocardiogram changes

    ST segment elevation or depression

    Time frame: baseline

  2. Echocardiography findings

    Systolic and diastolic left ventricular function

    Time frame: baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

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 10490436 ↗
  • Dunger 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 14736641 ↗
  • Gandhi 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.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03454152
Lead sponsor
Assiut University
Responsible party
Fatima Younis (Principal investigator, Assiut University) — Principal investigator
First posted
Mar 5, 2018
Start date
Mar 2019 (estimated)
Primary completion
Mar 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Mar 5, 2018

Study contacts

Hanaa Mohammad, prof
Contact
hae50@hotmail.com
01064747613
Hekma Farghaly, Dr
Contact
hekma73@hotmail.com
01091251040

Oversight

Data monitoring committee
No
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 Mar 2018. You cannot join it, but the record below documents what was studied.

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