Feeding Study - Effects Post-cardiac Surgery

Not Applicable

Completed

• Conditions: Heart Disease; Insulin Resistance; Dietary Modification
• Interventions: Dietary Supplement: Rapid advancement of feeds; Dietary Supplement: Standard advancement of feeds

• Registration Number: NCT02274220
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Primary Completion: 2017-03
• Study Completion: 2017-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid Advancement of Feeds	Rapid advancement of feeds	Postoperative feeds are initiated on first postoperative day and rapidly advanced over 27 hours.
Average feeding protocol	Standard advancement of feeds	Postoperative feeds are initiated on first postoperative day and advanced in using a standardized protocol that best-reflects current feeding practice. Maximum feeding volume is reached at 60 hours.

Primary Outcome Measures

Name	Time	Method
Insulin resistance	96 hours	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

Secondary Outcome Measures

Name	Time	Method
Number of subjects achieving goal feeds	96 hours
Postoperative systemic inflammation	96 hours	Serial measurements of postoperative cytokine (IL-1beta, IL-6, IL-8, IL-10 and TNFalpha) concentrations
Cardiac output	96 hours	Postoperative cardiac output measured by respiratory mass spectrometry and Fick equation
Morbidity score	96 hours	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.
Number of subjects with NEC/feeding intolerance/protocol violations	96 hours

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada