| CTRI Number |
CTRI/2024/02/062309 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study of Serum HDL, Serum Creatinine and Serum C-reactive protein in assessing severity of sepsis. |
|
Scientific Title of Study
|
Comparison of Serum HDL, Serum Creatinine, Serum C-reactive protein as predictors of severity in 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 |
Shivangi Singh |
| Designation |
Post Graduate Trainee |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Calcutta National Medical College and Hospital.
Department of Anaesthesiology
32,Gorachand Road,
Beniapukur,Kolkata.
Emergency Building,4th Floor.
Kolkata
WEST BENGAL
700014
India |
| Phone |
7003045433 |
| Fax |
|
| Email |
shivangisingh21.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sudeshna Bhar (Kundu) |
| Designation |
Associate Professor |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Calcutta National Medical College and Hospital.
Department of Anaesthesiology
32,Gorachand Road,
Beniapukur,Kolkata.
Emergency Building, 4th Floor
Kolkata
WEST BENGAL
700014
India |
| Phone |
8777725424 |
| Fax |
|
| Email |
sudeshna04cmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shivangi Singh |
| Designation |
Post Graduate Trainee |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Calcutta National Medical College and Hospital.
Department of Anaesthesiology
32,Gorachand Road,
Beniapukur,Kolkata.
Emergency Building, 4th floor
Kolkata
WEST BENGAL
700014
India |
| Phone |
7003045433 |
| Fax |
|
| Email |
shivangisingh21.ss@gmail.com |
|
|
Source of Monetary or Material Support
|
| Calcutta National Medical College and Hospital.
Kolkata-700014
West Bengal
Department of Anaesthesiology
32,Gorachand Road,
Beniapukur,Kolkata.
Emergency Building,4th Floor |
|
|
Primary Sponsor
|
| Name |
Calcutta National Medical College and Hospital |
| Address |
32,Gorachand Road,
Beniapukur, Kolkata,
West Bengal.
Pin code-700014
|
| 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 Shivangi Singh |
Calcutta National Medical College and Hospital |
Department of Anaesthesiology,
32,Gorachand Road,
Beniapukur,
Emergency Building, 4th Floor,
Kolkata,
West Bengal.
Pin code-700014
Kolkata
WEST BENGAL |
7003045433
shivangisingh21.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Calcutta National Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil. |
Nil. |
| Comparator Agent |
Nil. |
Nil. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age greater than 18 years and satisfying the criteria for sepsis according to International guidelines for management of severe sepsis and septic shock. |
|
| ExclusionCriteria |
| Details |
1. Patients on treatment with statins.
2. Patients with chronic kidney disease, chronic liver disease, thyroid dysfunction, diabetes mellitus, and malabsorption disorders.
3. Patients with known chronic infective and inflammatory conditions like Human immunodeficiency virus disease, SLE(Systemic lupus erythematous) and RA( Rheumatoid arthritis) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
The SOFA Score of patients who survives will be low and those who do not survive the score
will be high. The three parameters may show the following outcomes:
(i)The serum HDL-cholesterol values may be low in non survivors and may be high or within
normal limits among the survivors.
(ii)The serum CRP values are likely to be high among the non survivors and low among the
non survivors.
(iii)The serum creatinine levels are likely to be high in patients who will be progressing
towards septic shock and MODS and finally death. |
Twelve months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
All the three parameters in this study i.e. serum HDL, serum Creatinine, serum C- reactive protein will help in determining the disease progression in the
patient so that prompt action can be taken in appropriate time to alter the course of disease
with treatment modifications if possible, depending upon the patient’s clinical condition. |
Twelve months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/02/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
“Comaparison of serum HDL, serum Creatinine, serum C-reactive protein as predictors of severity in sepsis †is a prospective, observational study, that will be conducted in the surgical ICU of Calcutta National Medical College and Hospital involving 40 sepsis patients. The severity of the illness will be scored by SOFA score. Serum HDL, serum creatinine , serum CRP levels and the variables required for SOFA score will be measured at four intervals ,at the time of admission in intensive care unit i.e. day one, on day three, on day five and on day seven. The correlation between SOFA scores and serum HDL, serum creatinine and serum CRP levels will be assessed. All the three parameters in this study will help in determining the disease progression in the patient so that prompt action can be taken in appropriate time to alter the course of disease with treatment modifications if possible, depending upon the patient’s clinical condition. |