Micronutrients in Children in Critical Care With Cardiac Conditions

Completed

• Conditions: Heart Defects, Congenital

• Registration Number: NCT02409706
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

This study aims to explore the frequency and types of micronutrient deficiencies in a sample of UK children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

Detailed Description

Congenital heart disease (CHD) is one of the most common birth defects in the UK. Children with CHD are at risk of underfeeding and undernutrition. This is due to both the increased nutritional requirements of the disease and sometimes clinical management, which often hinders delivery of optimal nutrition.There are as yet no studies assessing micronutrient body stores in children with CHD or whether micronutrient deficiencies predict poor clinical outcomes, such as post-operative complications, after major cardiac operations.

This study aims to explore the frequency, types and associations of micronutrient deficiencies in children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Primary Completion: 2016-01
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Infant or child admitted for elective congenital cardiac surgery at the Royal Hospital for Sick Children, Glasgow.
• Aged less than 5 years old

Exclusion Criteria

• Infant or child admitted for emergency cardiac surgery
• Infant or child whose carer with parental responsibility is unable to communicate in English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Micronutrient Status	Pre- and post- operative: 24-48 hours	Micronutrient concentrations in plasma and erythrocytes

Secondary Outcome Measures

Name	Time	Method
Postoperative LOS	1 year	Length of hospital stay
Postoperative LICU	1 year	Length of stay in PICU
Postoperative Infectious complications	1 year	Incidence of infections
Postoperative ventilator time	1 year	Duration of ventilation

Trial Locations

Locations (1)

Royal Hospital for Sick Children; 🇬🇧 Glasgow, Glasgow City, United Kingdom