| CTRI Number |
CTRI/2024/03/063852 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative study of effectiveness of intravenous high dose of vitamin C and vitamin B1 in patients with severe infection. |
|
Scientific Title of Study
|
To compare efficacy of high dose Vitamin C infusion and Thiamine (vitamin B1) infusion in patients of sepsis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Agrawal |
| Designation |
Junior resident |
| Affiliation |
Upums saifai etawah |
| Address |
Department of anaesthesiology Uttar Pradesh University of medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9981724541 |
| Fax |
|
| Email |
ssonalii1813@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of medical sciences Saifai Etawah |
| Address |
Department of anaesthesiology Uttar Pradesh University of medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9455677608 |
| Fax |
|
| Email |
drprashant.mishra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Agrawal |
| Designation |
Junior resident |
| Affiliation |
Uttar Pradesh University of medical sciences Saifai Etawah |
| Address |
Department of anaesthesiology Uttar Pradesh University of medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9981724541 |
| Fax |
|
| Email |
ssonalii1813@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of medical sciences saifai etawah |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of medical sciences saifai etawah |
| Address |
Uttar Pradesh University of medical sciences saifai etawah uttar pradesh India pin code-206130 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Agrawal |
Uttar Pradesh university of medical sciences |
Department of anaesthesiology and critical care, surgical intensive care unit, Saifai
Etawah
UTTAR PRADESH |
9981724541
ssonalii1813@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee UPUMS Saifai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere, (2) ICD-10 Condition: B348||Other viral infections of unspecified site, (3) ICD-10 Condition: O85||Puerperal sepsis, (4) ICD-10 Condition: A419||Sepsis, unspecified organism, (5) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High dose vitamin B1 (Thiamine) infusion in patients of sepsis |
The patient of this group will receive 250mg vitamin C, 8 hourly( total dose 750 mg/day) for 5 days as an intravenous infusion mixed in 100 ml solution of either Dextrose 5% or normal saline along with standard treatment of sepsis. |
| Intervention |
High dose vitamin C infusion in patients of sepsis |
The patient of this group will receive 2.5 gram vitamin C, 8 hourly( total dose 7.5 gram/day) for 5 days as an intavenous infusion mixed in 100 ml solution of either Dextrose 5% or normal saline along with standard treatment of sepsis. |
| Comparator Agent |
Normal saline 0.9% or Dextrose 5% without any drug |
The patients of this group will be given only 100ml solution of either dextrose 5% or normal saline along with standard treatment of sepsis and no additional supplementation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with body mass index between 18 to 30
2.Patient who will not be on mechanical ventilator but fulfilling the criteria of sepsis at the time of inclusion for study
3.Patient who will be on standard treatment with similar antibiotics
4.Patient with SOFA score more than 2 but less than 8 will be included in the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or breastfeeding females
2.Moribund and not expected to survive 96 hours
3.Cancer as the cause of sepsis
4.Patients with chronic kidney disease, chronic alcoholics and immuno-compromised
patients. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the SOFA (Sequential Organ Failure Assessment) score. |
6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of ventilator associated pneumonia (VAP) if patient requires
mechanical ventilation after inclusion in study.
2. Duration of vasopressor therapy
3. CRP levels
4. Length of hospital stay
5. Mortality
6. Serious adverse events like ARDS, pulmonary embolism. |
6 days |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sonalijhansi@gmail.com].
- For how long will this data be available start date provided 03-03-2024 and end date provided 03-03-2015?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Sepsis is known as the main cause of death in critically ill
patients and is responsible for one-third to half of the hospital mortalities.
Sepsis is caused by an infectious organism, especially Gram-positive
infections, which triggers a local immune response. The migration of
neutrophils into the inflamed tissue will follow causing a release of free
radicals and inflammatory mediators which may trigger, in some patients, a systemic
inflammatory response syndrome (SIRS). SIRS may progress to severe sepsis, septic
shock, and multiple organ dysfunction syndrome (MODS. Supplementation of
vitamin C and thiamine in patients with sepsis remains an attractive therapeutic
target, considering the potential benefits, low costs and favourable safety
profile. Aim of the study is to compare the efficacy of vitamin c infusion with
thiamine (vitamin B1) infusion in patients of sepsis.
This is a prospective randomized double blind clinical
study. Study will be conducted on 75 patient with sepsis admitted in intensive
care unit . Patient will be randomized in 3 group 25 in each group. One group
will receive injection vitamin C, one group will receive injection Thiamine and
one group will receive placebo. Outcome data
will be analysed in terms of efficacy. |