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The effect of preoperative oral iron supplementation in anemic children with heart diseases by birth on postoperative outcomes

The effect of preoperative oral iron supplementation in anemic children with acyanotic congenital heart disease undergoing elective cardiac surgery on postoperative outcomes - A pragmatic randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047861
Enrollment
162
Registered
2022-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: iron syrup (tonoferon): colloidal iron - 3 mg/kg/day folic acid 80-300 mcg/day vitamin B12 - 0.5-1.2mcg/day volume will be adjusted according to body weight, age and syrup composition C

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.CHILDREN BETWEEN 6 MONTHS TO 12 YEARS OF AGE AND ACYANOTIC CONGENITAL HEART DISEASE UNDERGOING ELECTIVE CARDIAC SURGERY 2.HEMOGLOBIN < 12 g/dl

Exclusion criteria

Exclusion criteria: 1. EMERGENCY SURGERY 2.HEMOGLOBINOPATHIES 3.HEMOGLOBIN 4.MALABSORPTION SYNDROME 5.HISTORY OF HEMATEMESIS 6.HISTORY OF IRON INTOLERANCE, ALLERGEY OR POOR COMPLIANCE 7.REFUSAL FOR ASSENT 8.RECEIVING IRON SUPPLEMENTATION

Design outcomes

Primary

MeasureTime frame
TO COMPARE THE AMOUNT OF ALLOGENIC BLOOD TRANSFUSIONS FROM THE DAY OF RANDOMIZATION TILL THE TIME TO DISCHARGE FROM HOSPITAL DURING INDEX HOSPITALIZATIONTimepoint: FROM THE DAY OF RANDOMIZATION TILL THE TIME TO DISCHARGE FROM HOSPITAL DURING INDEX HOSPITALIZATION—

Secondary

MeasureTime frame
TO COMPARE 1.LENGTH OF HOSPITAL STAY 2.DURATION OF MECHANICAL VENTILATION 3.SURGICAL SITE INFECTION 4.ACUTE KIDNEY INJURY 5.MAJOR ADVERSE CARDIAC EVENTS 6.PULMONARY COMPLICATIONS 7.DEATH WITHIN 30 DAYS 8.DAYS ALIVE FROM THE DAY OF PLANNED SURGERY TILL 30TH DAY AFTER INDEX HOSPITALIZATION 9.READMISSION TO THE HOSPITAL WITHIN 6 MONTHS Timepoint: FROM THE DAY OF RANDOMIZATION TILL THE TIME TO DISCHARGE FROM HOSPITAL DURING INDEX HOSPITALIZATION—

Countries

India

Contacts

Public ContactABISHEK

JIPMER

drajaykjha@rediffmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026