Study of vitamin D level modification on mortality rate and postoperative complications in children after VSD repair surgery

Not Applicable

• Conditions: Ventricular septal defect; Q21.0; Ventricular septal Defect.

• Registration Number: IRCT20200123046231N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Patient undergo open heart surgery using a heart pump and pulmonary pump
Age range from one month to six years
Parents of children have informed consent to study

Exclusion Criteria

Patient's parents' unwillingness to participate in the study
Complex heart disease
Emergency surgery
Multi-stage surgery
Died during the intervention
Children with abnormal blood albumin or PTH levels will be excluded.Children who take vitamin D concomitantly with corticosteroid drugs such as prednisolone, anticonvulsants such as phenobarbital and phenytoin, and tuberculosis drugs such as rifampin and isoniazid with various mechanisms including decreased calcium absorption, decreased vitamin D absorption, increased metabolism of vitamin D and vitamin D Reduces the effect of vitamin D. Therefore, they need to increase their vitamin D intake
Children with a positive family history of kidney stones that are inherently higher in vitamin D will be excluded from the study
Children who use anesthetic drugs that interfere with vitamin D levels during cardiopulmonary bypass will be excluded

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum vitamin D levels in children. Timepoint: Baseline, before surgical incision, 24 hours after surgery. Method of measurement: HPLC method.

Secondary Outcome Measures

Name	Time	Method
Mortality rate. Timepoint: After surgery. Method of measurement: Follow-up until discharge.;Inotrop Score. Timepoint: when detached from Cardiopulmonary Machine, Highest in the first 24 ICU admissions. Method of measurement: Inotrope Score (IS) = Dopamine dose (mcg/kg/min) + Dobutamine dose (mcg/kg/min) + 100 x Epinephrine dose (mcg/kg/min).;Intubation Time. Timepoint: After surgery. Method of measurement: The patient's intubation hours after surgery.;Length of stay in intensive care unit. Timepoint: After surgery. Method of measurement: Days in the intensive care unit after surgery.;Duration of hospitalization. Timepoint: From patient admission to discharge. Method of measurement: Number of hospital days.