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Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial.

ABSTRACT: Vitamin D is a pleiotropic hormone important for the recovery of organ systems after critical illness. Recent observational studies have suggested that three out of every four children are vitamin D deficient following cardiac surgery, with inadequate preoperative intake and surgical losses playing important contributory roles. Observed associations between postoperative levels, cardiovascular dysfunction and clinical course suggest that perioperative optimization of vitamin D status could improve outcome. With this two-arm, parallel, double blind, randomized controlled trial (RCT), we aim to compare immediate postoperative vitamin D status in children requiring cardiopulmonary bypass for congenital heart disease who receive preoperative daily high dose vitamin D supplementation (high-dose arm) with those who receive usual intake (low-dose arm).Eligibility requirements include age (>36 weeks, <18 years) and a congenital heart defect requiring cardiopulmonary bypass surgical correction. Enrollment of 62 participants will take place at a single Canadian tertiary care center over a period of 2 years. Children randomized to the high-dose group will receive age-based dosing that was informed by the Institute of Medicine (IOM) daily tolerable upper intake level (<1 year old = 1,600 IU/day, >1 year old = 2,400 IU/day). Children in the low-dose arm will receive usual care based on IOM recommendations (<1 year old = 400 IU, >1 year old = 600 IU). The primary outcome measure is immediate postoperative vitamin D status, using blood 25(OH)D.Maintaining adequate postoperative vitamin D levels following surgery could represent an effective therapy to speed recovery following CHD surgery. The proposed research project will determine whether preoperative supplementation with a dosing regimen based on the IOM recommended daily upper tolerable intake will prevent postoperative vitamin-D deficiency in the majority of children. The results will then be used to inform the design of a large international RCT exploring whether preoperative optimization of vitamin D status might improve short and long-term outcomes in this vulnerable population.Clinicaltrials.gov Identifier--NCT01838447 Date of registration: 11 April 2013.

SUBMITTER: McNally JD

PROVIDER: S-EPMC4564959 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial.

McNally J Dayre JD O'Hearn Katie K Lawson Margaret L ML Maharajh Gyaandeo G Geier Pavel P Weiler Hope H Redpath Stephanie S McIntyre Lauralyn L Fergusson Dean D Menon Kusum K

Trials 20150909

<h4>Background</h4>Vitamin D is a pleiotropic hormone important for the recovery of organ systems after critical illness. Recent observational studies have suggested that three out of every four children are vitamin D deficient following cardiac surgery, with inadequate preoperative intake and surgical losses playing important contributory roles. Observed associations between postoperative levels, cardiovascular dysfunction and clinical course suggest that perioperative optimization of vitamin D ...[more]

PMID: 26353829

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Project description:Background:The vast majority of children undergoing cardiac surgery have low vitamin D levels post-operative, which may contribute to greater illness severity and worse clinical outcomes. Prior to the initiation of a large phase III clinical trial focused on clinical outcomes, studies are required to evaluate the feasibility of the study protocol, including whether the proposed dosing regimen can safely prevent post-operative vitamin D deficiency in this high-risk population. Methods:We conducted a two-arm, double-blind dose evaluation randomized controlled trial in children requiring cardiopulmonary bypass for congenital heart disease. Pre-operatively, participants were randomized to receive cholecalciferol representing usual care (< 1?year = 400?IU/day, > 1?year = 600?IU/day) or a higher dose approximating the Institute of Medicine tolerable upper intake level (< 1?year = 1600?IU/day, > 1?year = 2400?IU/day). The feasibility outcomes were post-operative vitamin D status (primary), vitamin D-related adverse events, accrual rate, study withdrawal rate, blinding, and protocol non-adherence. Results:Forty-six children were randomized, and five withdrew prior to surgery, leaving 41 children (21 high dose, 20 usual care) in the final analysis. The high dose group had higher 25-hydroxyvitamin D concentrations both intraoperatively (mean difference + 25.9?nmol/L; 95% CI 8.3-43.5) and post-operatively (mean difference + 17.2?nmol/L; 95% CI 5.5-29.0). Fewer participants receiving high-dose supplementation had post-operative serum 25-hydroxyvitamin D concentrations under 50?nmol/L, compared with usual care (RR 0.31, 95% CI 0.11-0.87). Post-operative vitamin D status was associated with the treatment arm and the number of doses received. There were no cases of hypercalcemia, and no significant adverse events related to vitamin D. While only 75% of the target sample size was recruited (limited funding), the consent rate (83%), accrual rate (1.5 per site month), number of withdrawals (11%), and ability to maintain blinding support feasibility of a larger trial. Conclusions:Pre-operative daily high-dose supplementation improved vitamin D status pre-operatively and at time of pediatric ICU admission. The protocol for a more definitive trial should limit enrollment of children with at least 30?days between randomization and surgery to allow adequate duration of supplementation or consider a loading dose. Trial registration:ClinicalTrials.gov, NCT01838447. Registered on April 24, 2013.

Project description:BACKGROUND:Postoperative delirium is common in elderly cardiac surgery patients. It is multifactorial and is influenced by the patient's baseline status and the nature of the medical and surgical interventions that the patient receives. Some of these factors are potentially modifiable, including postoperative sedation and analgesia protocols. This study has been designed to evaluate the effectiveness of postoperative intravenous acetaminophen in conjunction with either dexmedetomidine or propofol in decreasing the incidence of delirium. METHODS:This is a prospective, randomized, placebo-controlled, double-blinded, factorial trial that includes patients who are at least 60 years old and who are undergoing cardiac surgeries involving cardiopulmonary bypass, including coronary artery bypass graft (CABG) and combined CABG/valve surgeries. Patients are randomly assigned to receive one of four postoperative analgesic-sedation regimens: (1) acetaminophen and dexmedetomidine, (2) acetaminophen and propofol, (3) dexmedetomidine and placebo, or (4) propofol and placebo. The primary outcome, incidence of delirium, will be assessed with the Confusion Assessment Method (CAM or CAM-ICU). The secondary outcome, postoperative cognitive decline, will be assessed with the Montreal Cognitive Assessment. Additional secondary outcomes, including duration of delirium, postoperative analgesic requirement, length of stay, and incidence of adverse events, will also be reported. Data will be analyzed in 120 randomly assigned patients who received at least one dose of the study medication(s) on a modified intention-to-treat basis. DISCUSSION:This study has been approved by the institutional review board at Beth Israel Deaconess Medical Center, and the trial is currently recruiting. This study will systematically examine the implications of modification in postoperative sedative/analgesic protocols after cardiac surgery, specifically for short- and long-term cognitive outcomes. Any positive outcomes from this study could direct simple yet effective practice changes aimed to reduce morbidity. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02546765 , registered January 13, 2015.

Project description:BackgroundEffective nutrition programs are beneficial for nutritional recovery in infants. Few studies have focused on the effect of early high-energy feeding after open heart surgery. This study sought to assess the effects of early high-energy feeding in infants after congenital heart surgery.MethodsPatients at a tertiary pediatric cardiology center who underwent open heart surgery between July 2016 and July 2018 were recruited and randomly allocated to 1 of the following 2 groups: (I) the intervention group (postoperative early high-energy feeding; n=124); and (II) the control group (no intervention; n=120).The primary endpoints of average energy delivery and growth Z-scores [i.e., weight-for-height Z-score (WHZ), weight-for-age Z-score (WAZ), and height-for-age Z-score (HAZ)] were recorded preoperatively, during the intensive care unit (ICU) stay, at discharge, and at 1 and 3 months postoperatively. The secondary endpoints of malnutrition recovery, ventilator support time, infection rate, and cardiac ICU (CICU) stay were also recorded.ResultsA total of 244 infants were included in the study. There were no significant differences in the baseline features between the 2 groups. The intervention group received higher calories on average than the control group (44.5 vs. 34.7; P<0.001). At discharge from the ICU, the WHZ (-2.29 vs. -2.76; P<0.001) and WAZ (-3.08 vs. -3.43; P=0.005) of patients in the intervention group were higher than those of patients in the control group. Ventilator support time (P=0.004), CICU stay (P=0.045), and infection rate (P=0.001) were significantly lower in the intervention group than the control group. At 3 months post-surgery, the intervention group exhibited a higher malnutrition recovery rate than the control group (19.4% vs. 6.5%; P=0.002).ConclusionsThe administration of early high-energy feeding to infants after congenital heart surgery is associated with improved growth, reduced CICU stay, decreased ventilator support time, and reduced postoperative infection rates.Trial registrationClinicalTrials NCT04609358.

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Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial.

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Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial.

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