| CTRI Number |
CTRI/2023/09/057693 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study alterations in the Thyroid profile in patients with Sepsis as prognostic marker |
|
Scientific Title of Study
|
A Study of Thyroid profile in patients with 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 AKSHARA MANIKANDAN |
| Designation |
Junior Resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE,KASTURBA MEDICAL COLLEGE,MANIPAL,576104
Udupi
KARNATAKA
576104
India |
| Phone |
7892359819 |
| Fax |
|
| Email |
aksharamanikandan97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M Mukhyaprana Prabhu |
| Designation |
Professor and Unit Head |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE,KASTURBA MEDICAL COLLEGE,MANIPAL,576104
Udupi
KARNATAKA
576104
India |
| Phone |
9632118700 |
| Fax |
|
| Email |
mm.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR AKSHARA MANIKANDAN |
| Designation |
Junior Resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE,KASTURBA MEDICAL COLLEGE,MANIPAL,576104
Udupi
KARNATAKA
576104
India |
| Phone |
7892359819 |
| Fax |
|
| Email |
aksharamanikandan97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Manipal |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Private 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 Akshara |
Kasturba Medical College |
Department of General Medicine,Kasturba Hospital,Manipal
Udupi
KARNATAKA |
07892359819
aksharamanikandan97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital IEC W |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed to have sepsis:Culture proven or visually identified infection accompanied by two or more of the following :
Heart rate->90 beats per minute
Temperature->38 or <36 degree Celsius
Respiratory rate->20 breaths per minute or PaCO2<32mmhg
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Patients who are diagnosed to have thyroid disease- hypothyroidism,hyperthyroidism,thyroid
nodule
3.Patients on drugs which alter thyroid functions such as amiodarone, dopamine, and
phenytoin,steroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the mortality of patients with sepsis on day 28 of admission, based on thyroid hormone levels done on 1st day of admission. |
At baseline and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate thyroid dysfunction with SOFA score in critically ill patients with sepsis on day of admission
To compare thyroid hormone assessment in septic patients with C-reactive protein on day of admission |
At baseline & at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
22/09/2023 |
| 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="6"
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
|
Abnormal ‘‘thyroid function test†results have often been noticed in patients suffering from various infections, because the thyroid hormone plays an important role in the adaptation of metabolic function to stress and critical illness..Thyroid profile is altered in many patients with sepsis.Hence,it can be used as a prognostic factor in sepsis,along with other variables and scores. In the future their re-placement may play some role in sepsis management |