Feeding Study - Effects Post-cardiac Surgery

Insulin Resistance Clinical Trial

Official title:

Randomized Study of Early Nutritional Delivery on Glucose Control, Insulin Resistance and Systemic Inflammation Following Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274220
• Other study ID #: 1000046036
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized trial is to clarify the role of enteral nutrition (EN) on the relationship between cardiopulmonary bypass-induced inflammation and insulin resistance by investigating the effects of two different feeding strategies in infants following cardiac surgery. The study's primary objective is to determine if early and higher volume feeding modifies the relationship between the severity of postoperative systemic inflammation and insulin resistance.

Description:

Good nutrition is important for patients after surgery. Patients who are given food tend to have fewer infections, better wound healing, and are possibly discharged more quickly from the intensive care unit and hospital. However, the best time to start feeds and the speed at which they can be increased is unclear. This may be particularly true for young children who have undergone heart surgery using a heart-lung bypass machine (bypass surgery). Bypass surgery can cause inflammation that can change the way the body uses energy and nutrients. Specifically, after bypass the body can become insensitive to insulin (insulin resistant), which means that the cells in the body don't take up sugar from the blood like they are supposed to, and this may lead to complications from the surgery. In a recent study we found that inflammation and insulin resistance was not associated with as many complications in children who were being fed. We are not sure if feeding changed the way in which the body responded after surgery or if doctors chose to feed only patients who were already recovering well. In general, doctors often hesitate to feed patients immediately after surgery because they worry that the body may not be ready for food although there is not much information to prove that this worry is correct. Starting feeds early using a structured feeding plan may be good during the recovery from heart surgery, even in our most vulnerable patients. We therefore designed this study to see if starting feeds early after bypass surgery and increasing them more quickly than our usual routine would decrease inflammation and insulin resistance. We will only study children younger than 6 months of age because they are at higher risk of complications from bypass surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• less than 6 months of age

• weight > 2.5kg

• surgery using cardiopulmonary bypass

• expected duration of ventilation > 6 hours

Exclusion Criteria:

• cardiac transplantation

• prematurity (<37 weeks gestation AND under 28 days of life)

• intrauterine growth restriction

• NEC

• structural gastrointestinal anomalies

• known preoperative feeding intolerance

• diabetes or known metabolic disorder

• preoperative liver or renal dysfunction

• postoperative contraindication to enteral feeding as determined by clinical team

• previous enrollment at an earlier operation

• in the opinion of the clinical or research team the patient is too well to participate, such that slow escalation to feeds would lead to hunger and therefore be considered inappropriate.

Related Conditions & MeSH terms

• Dietary Modification
• Heart Disease
• Heart Diseases
• Insulin Resistance

Intervention

Dietary Supplement:
• Rapid advancement of feeds
Feeding is initiated on first postoperative day. Bolus feeds are started at 1 mL/kg every three hours and up-titrated by 1 mL/kg every feed (Q 3 hours) to a goal of 10 mL/kg/feed (equivalent to approximately 50 kcal/kg/day). Feeding volume will exceed 20 mL/kg/day by 6 hours following protocol initiation and reach target feeds by 27 hours of protocol initiation.
• Standard advancement of feeds
Feeding is initiated on first postoperative day. Bolus feeds are started at 3 mL every three hours for 24 hours. Bolus feeds then up-titrated by 1 mL/kg every-other feed (Q 6 hours) for 24 hours. Bolus feeds then up-titrated by 1mL/kg every feed for to a goal of 10 mL/kg/feed (equivalent to approximately 50 kcal/kg/day). Feeding volume will reach target feeds by 60-63 hours after protocol initiation.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	Plasma insulin concentrations and glucose-insulin ratio (GIR) - GIR will be calculated at each time point and used to reflect insulin resistance, with lower values representing increased resistance	96 hours
Secondary	Postoperative systemic inflammation	Serial measurements of postoperative cytokine (IL-1beta, IL-6, IL-8, IL-10 and TNFalpha) concentrations	96 hours
Secondary	Cardiac output	Postoperative cardiac output measured by respiratory mass spectrometry and Fick equation	96 hours
Secondary	Morbidity score	Postoperative morbidity assessed by a composite morbidity score that includes death, cardiac arrest, use of extracorporeal membrane oxygenation, cardiogenic shock, acute kidney injury, hepatic injury, or hospital-acquired infection.	96 hours
Secondary	Number of subjects achieving goal feeds		96 hours
Secondary	Number of subjects with NEC/feeding intolerance/protocol violations		96 hours