Nutritional Optimization in Anemic Patients Scheduled for Elective Open-Heart Surgery

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Institute of Cardiovascular Diseases, Pakistan

About this trial

1. To test the effect and feasibility of culturally relevant SNP program in Anaemic patients scheduled for elective open-heart surgery versus those getting usual preoperative care in a public sector hospital. 2. To evaluate the incidence of transfusion during intra-operative and postoperative periods among cardiac patients undergoing elective open-heart surgery who receive iron correction therapy as part of the Solo Nutrition Prehabilitation (SNP) program

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years) scheduled for elective open heart surgery (CABG), with a minimum preoperative waiting period of 8-12 weeks and presenting with preoperative hemoglobin levels of 10-11 g/dL in females and 11-12 g/dL in males, were eligible for inclusion in the study. No Female below 9 and male below 11 will be recruited.

Moderate to good LV (EF 40 and above)

Disqualifiers

Emergency cases requiring immediate surgery

Pregnant females

Patients with any type of malignancy, that limits their life expectancy at the time of admission

Hepatic disease of any Kind

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immune Modulating Formula, Whey Protein, Multivitamins and Iron Supplements

    Dietary supplement

    Educational brochures include iron rich dietary guide and education related to presurgery diet modification and nutritional buildup.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: intervention groupExperimental treatment 1 intervention
Group B: Controlled groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Blood transfusion

incidence of blood transfusion needed during intra-op, incidence of blood transfusion post-op, transfusion needed in ICU in the first 24 hours, transfusion in the ward, total transfusions done throughout the course of stay in the hospital

Time frame
From enrollment date to the end of treatment at 8 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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