Parenteral Nutrition Supplement BFLUID in Post-Operative Participants (Gastrectomy & Colectomy)

Phase 3

• Conditions: Health Condition 1: E639- Nutritional deficiency, unspecified

• Registration Number: CTRI/2021/01/030728
• Lead Sponsor: Otsuka Pharmaceutical India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Length of hospital stayTimepoint: 1.Day of Hospitalization to day of discharge (V3 to V7)

Secondary Outcome Measures

Name	Time	Method
1.Incidents of infections and mortality <br/ ><br>2.Change in blood levels of vitamin B1 from baseline to post end of infusion <br/ ><br>3.Change in nutritional parameters from baseline to day of discharge <br/ ><br>4.Assessment of thrombophlebitis and pain at injection site <br/ ><br>5.Recording of adverse events <br/ ><br>6.Change in laboratory parameters <br/ ><br>Timepoint: 1.V2 to V7 <br/ ><br>2.V4 (Start of Infusion) to V5 (End of Infusion) <br/ ><br>3.V2 (Baseline) to V7 (day of discharge) <br/ ><br>4.V4 to V7 <br/ ><br>5.V1 to V7 <br/ ><br>6.V1 to V7 <br/ ><br>