Feeding Study - Effects Post-cardiac Surgery

The Hospital for Sick Children

Status: Completed

Conditions: Insulin Resistance; Dietary Modification; Heart Disease

Treatments: Dietary Supplement: Rapid advancement of feeds; Dietary Supplement: Standard advancement of feeds

Study type: Interventional

Funder types: Other

Identifiers

NCT02274220

1000046036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 1 minute to 6 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 3 patient groups

Rapid Advancement of Feeds

Experimental group

Description:

Postoperative feeds are initiated on first postoperative day and rapidly advanced over 27 hours.

Treatment:

Dietary Supplement: Rapid advancement of feeds

Average feeding protocol

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Standard advancement of feeds

Feeds not affected

No Intervention group

Description:

Postoperative feeds for patients not eligible for randomization are initiated by the treating clinical team and increased as per clinical team's preference.