Clinical trial NCT03454152: Ecg & Echo Changes in Children With DKA
Official title: Electrocardiogram and Echocardiography Changes in Children With Diabetic Ketoacidosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All pediatric patients with diabetic ketoacidosis come to Assuit University Children Hospital within one year.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: Echocardiography parameters
timeFrame: baseline
measure: Electrocardiogram parameters
timeFrame: baseline
Secondary outcomes:
measure: Electrocardiogram changes
timeFrame: baseline
measure: Echocardiography findings
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: Gandhi MJ, Suvarna TT. Cardiovascular complications in diabetic ketoacidosis. Int J Diab Dev Countries. 1995;15:132-133.
citation: Chung EK. Electrolyte imbalance and cardiac arrhythmias. In : Principles of Cardiac Arrhythmias. Edward Chung (ed.) Williams and Wilkins, 1989.