To compare the effectiveness of Thiamine in combination with Vitamin C and it’s combination with Glutamine on survival outcome in critically ill patients admitted in ICU

Not yet recruiting

• Conditions: Thiamine deficiency, unspecified, (2) ICD-10 Condition: E519||Thiamine deficiency, unspecified,

• Registration Number: CTRI/2023/03/050828
• Lead Sponsor: Manjeeta Kumari

Brief Summary

This study will be conducted after approval of Institute ethics committee. Patient morbidities and improvements in ICU will be correlated with administration of Thiamine in combination with Vitamin C or in combination of Thiamine with Glutamine. Thiamine administration: 2mg/kg IV as an initial dose followed by 1-2 mg/kg/day  IV until the patient is on a regular, balanced, diet. Supplementing vitamin C 1 g twice daily to critically ill patients. Dose of glutamine 0.3-0.5 g/kg/day administered intravenously.

Their outcome will be studied under followings:

·        Duration of ICU stay.

·       Effect on SOFA score.

·       Effect on mortality of patients.

·       Number of free days of ventilation.

Demographic profile like age, sex and BMI and cause of ICU admission and associated comorbidities will be recorded. Patients will be categorized into two groups depending on the treatment plan:

Group-I: Patients with administration of Thiamine and Vitamin C.

Group-II: Patients with administration of Thiamine and Glutamine.

Clinical improvements in parameters will be noted and corelated among each group till patient stays in ICU.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-18
• Study Start: 2023-03-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• •Adult patients (18.
• 65 years old) admitted ICU patients. •Base line SOFA Score of individual at time of admission.

Exclusion Criteria

• •Patients who are taking drugs that affect vitamins absorption and metabolism.
• •Patients admitted to ICU for post operative monitoring or undergoing blood purifications.
• •Patients on regular haemodialysis or plasmapheresis or on going bleeding.
• •Extreme of ages i.e children < 18yrs and old age > 65 yrs.
• •Patients whose chances of survival is very less.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary outcome as the effect on mortality with treatment among critically ill patients	Outcome observed till first 10 days of treatment and further till 28 days of treatment.

Secondary Outcome Measures

Name	Time	Method
oDuration of ICU stay.	oEffect on SOFA score.

Trial Locations

Locations (1)

Medical ICU, Indiragandhi institute of medical sciences, Anaesthesia department, Patna; 🇮🇳 Patna, BIHAR, India

Medical ICU, Indiragandhi institute of medical sciences, Anaesthesia department, Patna

🇮🇳Patna, BIHAR, India

drarvind kumar

Principal investigator

9534870908

arvind007kumar@yahoo.com