A Multi-center, Open Label, Single Arm, Prospective, Observational Study to Evaluate the Effectiveness and Safety of Whey Protein Isolate (WPI) Based Nutritional Supplement in Coronary Artery Bypass Surgery (CABG) Patients - NI

Otsuka Pharmaceutical India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•1. Patients with age of = 18 to 70 years and with the clinical diagnosis of CAD (coronary artery disease) undergoing CABG surgery.
•2. Patients/LAR who are willing to provide voluntary written informed consent to participate in the study.
•3. Patients receiving nutrition as per standard care.
•4. Expected length of ICU/hospital stay is minimum 5 days.
•5. Patients who in the opinion of physician are suitable to receive oral WPI based nutritional supplement.
•6. Patients who will be able to adhere to study visit schedule and other protocol requirements.
•After the screening and confirmation, the patient will receive Whey Protein Isolate based nutritional supplement 24-48 hrs. after the CABG surgery based on discretion of physician/dietician for 30 days

•1. Patients taking enteral (tube feeding) or parenteral nutritional supplements or any other form of protein supplement.
•2. Patients having known allergy or contraindication for use of WPI based nutritional supplements.
•3. Pregnant or breastfeeding women.
•4.Patients with BMI >30 kg/m2.
•5. Patient with severe and life-threatening complication(s) or patients who are unlikely to survive the next 48-72 hrs. at the time of enrollment (as per physician’s discretion).
•6. Patients using other experimental drugs or participating in other clinical trial in the prior one month.
•7. Any clinical condition that would preclude participation in the study as per investigator’s opinion.

发起方

Otsuka Pharmaceutical India Pvt Ltd