CTRI/2021/01/030728尚未招募3 期
Randomized, Parallel Group, Phase III Study to Compare Safety and Efficacy of BFLUID with a Commercially Available Solution, NUTRIFLEX PERI, as a Control Product in Patients Undergoing Gastrectomy or Colectomy
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:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female participants aged between >= 18 years to 70 years who are willing to provide signed written informed consent
- •2. Patients undergoing gastrectomy or colectomy deemed fit for PPN therapy
- •3. Negative urine pregnancy test for women of childbearing potential
- •4. Agree to comply with the study requirements
- •5. Patients with BMI >=18-30 kg/m2
排除标准
- •1.Those receiving multi-vitamin formulation (containing Vitamin B1) or Vitamin B1 as a standard multivitamin in the previous 3 days from Day 0.
- •2. Patients in ICU/HDU in the past 90 days from Day 0
- •3. Patients assessed as severely malnourished as per subjective global assessment (SGA)
- •4. Patients on parenteral nutrition during the last 7 days from Day 0
- •5.Patients currently undergoing chemotherapy and or radiotherapy cycles
- •6. Patients with serum albumin levels < 30 g/L
- •7. Patients with:
- •a. Uncontrolled diabetes (HbA1c >10%)
- •b. Known decompensated congestive cardiac failure (NYHA class III and IV â?? Appendix 2)
- •c. Major cardiovascular disorder (CVD) within last 6 months
- •d. Chronic kidney disease (CKD stage 3 and above i.e. eGFR < 60 mL/min/1.73m2)
- •8. Patients with chronic liver disease (Child-Pugh Class C- Appendix 1)
- •9. Patients with uncontrolled dyselectrolytemia at Day 0
- •10. Patients with a history of congenital abnormal amino acid metabolism
- •11. Those who have participated in any other clinical study within the previous 4 weeks prior to randomization
- •12. Patients with acute hepatitis in last 6 weeks, AST or ALT, exceeding 2.5 x upper limit of normal range, total bilirubin level more than 3.0 mg/dL
- •13. Patients with any serious clinical condition that would preclude participation in the study (in the opinion of the Investigator - includes pre-operative, intra-operative and immediate post-operative periods intervening the study)
- •14. Patients with a positive serology test result for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections
- •15. Pregnant or lactating women who intend to continue breast-feeding
- •16. Patients planned for transplant surgery
- •17. Patients with known sensitivity to thiamine hydrochloride
研究者
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