Feeding Study - Effects Post-cardiac Surgery

NCT02274220 | Completed DMC

• 1 other identifier: 1000046036
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Dietary Modification; Insulin Resistance

Keywords

systemic inflammation; glucose metabolism; glucose-insulin ratio

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative systemic inflammation

  96 hours

• Cardiac output

  96 hours

• Morbidity score

  96 hours

• Number of subjects achieving goal feeds

  96 hours

• Number of subjects with NEC/feeding intolerance/protocol violations

  96 hours

Study Arms (3)

Rapid Advancement of Feeds

EXPERIMENTAL

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

Dietary Supplement: Rapid advancement of feeds

Average feeding protocol

EXPERIMENTAL

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.

Dietary Supplement: Standard advancement of feeds

Feeds not affected

NO INTERVENTION

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

Interventions

Rapid advancement of feeds DIETARY_SUPPLEMENT

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.

Rapid Advancement of Feeds

Standard advancement of feeds DIETARY_SUPPLEMENT

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.

Average feeding protocol

Eligibility Criteria

• Age: 1 Minute - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• less than 6 months of age
• weight \> 2.5kg
• surgery using cardiopulmonary bypass
• expected duration of ventilation \> 6 hours

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Heart Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Steve Schwartz, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)