Effect of combined Vitamin C and B1 vs. vitamin C alone on inflammatory response in patients who undergoing valvular surgery.

Phase 4

• Conditions: 1. To evaluate the effect on inflammatory biomarker (C-reactive protein, C-RP) between group combined vitamin C & B1 and group vitamin C only.2. To evaluate hemodynamic parameters; systolic blood pressure, diastolic blood pressure and mean arterial pressure before induction to postoperatively period between-group combined vitamin C & B1 and group vitamin C only.3. To evaluate the percentage of left ventricular ejection fraction (LVEF) change from preoperative time to 24 hours after surgery between-group combine vitamin C+B1 and group vitamin C only; Vitamin C, vitamin B1, ischemic reperfusion injury, inflammatory response, valvular surgery

• Registration Number: TCTR20220430005
• Lead Sponsor: Faculty of medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-30
• Last Update Posted: 19 August 2024
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Scheduled for elective non-emergent valve repair or replacement
2. Aged 18 years or older
3. Left ventricular ejection fraction > 35%
4. No known coagulopathy prior to surgery

Exclusion Criteria

1. Administration of vitamin C and/or B1 in the previous 7 days
2. Known allergy to thiamine (B1) and vitamin C
3. Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic)
4. Research-protected populations (pregnant women, prisoners, the intellectually disabled)
5. Emergency cardiac surgery
6. Ejection fraction no less than 35%
7. Presence of autoimmune disease or currently receiving immunosuppressant therapy
8. History of renal calculi or urolithiasis
9. Patients who iron deficiency (e.g.,thalassemia, hemochromatosis)
10. Renal dysfunction (pre-operative creatinine clearance < 40 mL/min, or serum creatinine greater than 1.8 mg/dl)
11. known bleeding diathesis such as hemophilia, Von Willebrand's disease, or liver failure, or receiving concurrent anticoagulant therapy (such as warfarin, dabigatran, or apixaban) for venous or arterial thrombosis
12. Active infection, cancer, or tumor
13. Prior history of atrial fibrillation
14. Prisoner
15. Pregnancy
16. On mechanical ventilation on the day of surgery
17. Need vasopressor/inotropic agents on the day of surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate effect on inflammatory biomarker (C-reactive protein, C-RP) between group combined vitamin C & B1 and group vitamin C only. pre-op, immediate post-op, post-op day 1 plasma level of C-reactive protein

Secondary Outcome Measures

Name	Time	Method
evaluate hemodynamic parameters; systolic blood pressure, diastolic blood pressure and mean arterial pressure since before induction to postoperatively period between group before induction of anesthesia though postoperative day 1 systolic blood pressure, diastolic blood pressure, mean arterial blood pressure,evaluate percentage of left ventricular ejection fraction (LVEF) change from preoperative time to 24 hours after surgery before induction of anesthesia, and 24 hours postoperatively left ventricular ejection fraction by SIMPSON's BIPLANE METHOD