| CTRI Number |
CTRI/2024/07/070780 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective, longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
A study to correlate good Cholesterol levels and outcome in sepsis patients. |
|
Scientific Title of Study
|
A study of serum HDL Cholesterol levels in patients with sepsis and its prognostic significance. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kodali Alekhya |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7093702134 |
| Fax |
|
| Email |
kodali.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
M Mukhyaprana Prabhu |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9632118700 |
| Fax |
|
| Email |
mm.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
M Mukhyaprana Prabhu |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9632118700 |
| Fax |
|
| Email |
mm.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Kasturba Medical College, MAHE, Tiger circle road, Madhav Nagar, Eshwar nagar,Manipal ,Karnataka ,India , 576104 |
|
|
Primary Sponsor
|
| Name |
Kodali Alekhya |
| Address |
Department of General Medicine, Kasturba Medical College, Madhav Nagar,Manipal ,Karnatka , 576104. |
| Type of Sponsor |
Other [Kodali Alekhya (self)] |
|
|
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 Kodali Alekhya |
Kasturba Hospital |
Department of General Medicine, Kasturba medical college, MAHE ,Manipal,udupi ,Karnataka,india 576104.
Udupi
KARNATAKA |
7093702134
kodali.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- Student Research |
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 |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients admitted to ICU/HDU at Kasturba Hospital, 2. Must meet the criteria for sepsis according to
sepsis 3 guidelines (2 or more SOFA -sequential
organ failure assessment score). |
|
| ExclusionCriteria |
| Details |
1. Patients with thyroid dysfunction
2. Chronic kidney disease
3. Chronic liver disease
4. Pregnancy
5. Malignancy
6. Malabsorption
7. On drugs like steroids
8. Familial hyperlipidemias
9. Chronic inflammatory conditions like HIV, SLE,
rheumatoid arthritis
10. patients who left the hospital against medical advice
11. post operative sepsis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine correlation between HDL levels, mortality in patients admitted in ICU/HDU in sepsis. |
1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine correlation between HDL cholesterol and SOFA (sequential organ failure assessment score) |
on day of admission. |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
28/07/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Written and informed consent will be obtained from the patient or next of kin, if patient is unable to give consent, prior to enrolment into the study. Participants will be recruited from department of General Medicine and Critical Care admitted to ICU and HDU in sepsis according to the inclusion , exclusion criteria. A few questions would be asked to collect the socio demographic details, the illness details and patient file would be reviewed for lab reports and investigation results. Serum HDL cholesterol levels and , SOFA score (sequential organ failure assessment score) will be calculated for these patients within 24 hours of admission. Correlation between HDL cholesterol levels and SOFA score will be made and patient course in the hospital will be monitored up to the time of discharge or death. Patients need for intensive respiratory or vasopressor support will be noted and a correlation will be made between the SOFA score, serum HDL levels and the outcome of the patient. Data will be analyzed as per statistical methods and an association between the HDL levels and need for intensive respiratory or vasopressor support, number of days of ICU stay and in hospital mortality will be determined, so as to find out the prognostic significance of serum HDL cholesterol levels in patients with sepsis. |