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CTRI Number  CTRI/2023/03/050828 [Registered on: 20/03/2023] Trial Registered Prospectively
Last Modified On: 18/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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 
Scientific Title of Study   To compare the effectiveness of Thiamine in combination with Vitamin C and its combination with Glutamine on survival outcome in critically ill patients admitted in ICU. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manjeeta Kumari 
Designation  Junior Resident 1 
Affiliation  IGIMS, Patna 
Address  Anaeshthesia Dept, first floor, IGIMS, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone  7992250373  
Fax    
Email  manjeetasinha2k15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arvind Kumar 
Designation  Additional Professor 
Affiliation  IGIMS, Patna 
Address  Anaeshthesia Dept, first floor, IGIMS, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  arvind007kumar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Arvind Kumar 
Designation  Additional Professor 
Affiliation  IGIMS,Patna 
Address  Anaeshthesia Dept, first floor, IGIMS, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  arvind007kumar@yahoo.com  
 
Source of Monetary or Material Support  
Manjeeta Kumari, IGIMS, Patna 
 
Primary Sponsor  
Name  Manjeeta Kumari 
Address  Anaesthesia Dept, first floor, IGIMS, Sheikhpura, Patna 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
drarvind kumar  Medical ICU, Indiragandhi institute of medical sciences, Anaesthesia department, Patna  ward block, 1st floor igims,shekhpura,patna bihar
Patna
BIHAR 		 9534870908

arvind007kumar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E519||Thiamine deficiency, unspecified, (2) ICD-10 Condition: E519||Thiamine deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Thiamine with Glutamine   Thiamine: Intravenous injection 2mg/kg IV as an initial bolus dose followed by 1-2 mg/kg/day and Glutamine 0.3-0.5/kg body wt. Initial duration for 10 days. 
Intervention  Thiamine with Vitamin C  Thiamine: Intravenous injection 2mg/kg IV as an initial bolus dose followed by 1-2 mg/kg/day, Supplementing vitamin C 1 g Initial duration of administration- 10 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Adult patients (18 - 65 years old) admitted ICU patients.
• Base line SOFA Score of individual at time of admission.
 
 
ExclusionCriteria 
Details  • 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
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
o Duration of ICU stay.
o Effect on SOFA score.
o Number of free days of ventilation.
 		 till ICU stay 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   once the study completed. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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