Ecg & Echo Changes in Children With DKA

Pediatric Disorder Clinical Trial

Official title:

Electrocardiogram and Echocardiography Changes in Children With Diabetic Ketoacidosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03454152
• Other study ID #: DKA2018
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2018
• Last updated: March 2, 2018
• Start date: March 2019
• Est. completion date: June 2020

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: Hanaa Mohammad, prof
• Phone: 01064747613
• Email: hae50[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Chung EK. Electrolyte imbalance and cardiac arrhythmias. In : Principles of Cardiac Arrhythmias. Edward Chung (ed.) Williams and Wilkins, 1989.

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. Review. — View 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. — View Citation

Gandhi MJ, Suvarna TT. Cardiovascular complications in diabetic ketoacidosis. Int J Diab Dev Countries. 1995;15:132-133.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiography parameters	Right and left ventricular dimension during diabetic ketoacidosis and after correction.	baseline
Primary	Electrocardiogram parameters	QT interval and PR interval.	baseline
Secondary	Electrocardiogram changes	ST segment elevation or depression	baseline
Secondary	Echocardiography findings	Systolic and diastolic left ventricular function	baseline