Ecg & Echo Changes in Children With DKA

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03454152
Collaborator
(none)
60
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Electrocardiogram and Echocardiography Changes in Children With Diabetic Ketoacidosis
    Anticipated Study Start Date :
    Mar 1, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Jun 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Echocardiography parameters [baseline]

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

    2. Electrocardiogram parameters [baseline]

      QT interval and PR interval.

    Secondary Outcome Measures

    1. Electrocardiogram changes [baseline]

      ST segment elevation or depression

    2. Echocardiography findings [baseline]

      Systolic and diastolic left ventricular function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fatima Younis, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03454152
    Other Study ID Numbers:
    • DKA2018
    First Posted:
    Mar 5, 2018
    Last Update Posted:
    Mar 5, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 5, 2018