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IRCT20200123046231N1 IRCT 2020-02-01 Esfahan University of Medical Sciences Study of vitamin D level modification on mortality rate and postoperative complications in children after VSD repair surgery Study of vitamin D level correction on mortality rate and postoperative complications in children after VSD repair surgery in Shahid Chamran Hospital in Isfahan 2019-03-21 anticipated 64 Complete https://irct.ir/trial/45269 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Nothing. N/A Ventricular septal Defect. Intervention 1: Intervention group: Children referred to physicians who had inadequate vitamin D levels and underwent non-emergency surgery for ventricular septal defect repair were given 400 international units daily for children under one year and 600 international units for children over one year old. They were supplemented with vitamin D drops for a month or more. Intervention 2: Control group: Children on the list of non-emergency surgery for repair of the ventricular septal defect who did not have access to vitamin D level control. Yes - There is a plan to make this available What will be shared: All potential data is shared after unidentifiable people When: Start access period 4 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: All investigations should be conducted with the coordination of the researcher Where to obtain: Correspondence Email to mshefaat2005@gmail.com How to obtain: The data will be sent as a PDF file after obtaining written permission from the Vice President of Research and Technology of the University of Medical Sciences at least one month after the researchers request. Comments:
public Seyed Mansour Shafaat
Talar Ave, Pardis alley, No. 18
Isfahan Iran (Islamic Republic of) 8199917999 +98 31 3230 6139 mshefaat2005@gmail.com Esfahan University of Medical Sciences scientific Seyed Mansour Shafaat
Talar Ave, Pardis alley, No. 18
Isfahan Iran (Islamic Republic of) 8199917999 +98 31 3230 6139 mshefaat2005@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 1 month 6 years Both 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 Q21.0 Ventricular septal defect Other Other Intervention group: Children referred to physicians who had inadequate vitamin D levels and underwent non-emergency surgery for ventricular septal defect repair were given 400 international units daily for children under one year and 600 international units for children over one year old. They were supplemented with vitamin D drops for a month or more Control group: Children on the list of non-emergency surgery for repair of the ventricular septal defect who did not have access to vitamin D level control Serum vitamin D levels in children. Timepoint: Baseline, before surgical incision, 24 hours after surgery. Method of measurement: HPLC 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. Esfahan University of Medical Sciences Approved 2019-10-20 Ethics committee of isfahan university of medical sciences Hezar jarib in Blvd. Isfahan Isfehan Iran (Islamic Republic of)