Ecg & Echo Changes in Children With DKA

NCT03454152 | Unknown

• 1 other identifier: DKA2018
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric Disorder

Outcome Measures

Primary Outcomes (2)

• Echocardiography parameters

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

  baseline

• Electrocardiogram parameters

  QT interval and PR interval.

  baseline

Secondary Outcomes (2)

• Electrocardiogram changes

  baseline

• Echocardiography findings

  baseline

Study Arms (1)

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

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 10490436 BACKGROUND

• 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.

  PMID: 14736641 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

Central Study Contacts

Hanaa Mohammad, prof

CONTACT

01064747613; hae50@hotmail.com

Hekma Farghaly, Dr

CONTACT

01091251040; hekma73@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: March 5, 2018
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 5, 2018

Record last verified: 2018-03