| CTRI Number |
CTRI/2021/09/036242 [Registered on: 06/09/2021] Trial Registered Prospectively |
| Last Modified On: |
03/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Comparative |
| Study Design |
Other |
|
Public Title of Study
|
Inflammatory markers for prognosis of sepsis and septic shock |
|
Scientific Title of Study
|
A qualitative evaluation of procalcitonin (PCT), Creactive protein (CRP) and
interleukin-6 (IL-6) for prognosis of sepsis & septic shock. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Upadhyay |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
BLK-MAX Super Speciality Hospital |
| Address |
Department of Critical Care Medicine, BLK-MAX Super Speciality Hospital,Pusa Road, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
Pusa Road, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
8447927104 |
| Fax |
|
| Email |
dr.vishalupadhyay@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradyut Bag |
| Designation |
Senior Consultant Critical Care Medicine |
| Affiliation |
BLK-MAX Super Speciality Hospital |
| Address |
Department of Critical Care Medicine, BLK-MAX Super Speciality Hospital,Pusa Road, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
Pusa Road, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
9999879975 |
| Fax |
|
| Email |
drpbag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Upadhyay |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
BLK-MAX Super Speciality Hospital |
| Address |
Department of Critical Care Medicine, BLK-MAX Super Speciality Hospital,Pusa Road, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
Pusa Road, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
8447927104 |
| Fax |
|
| Email |
dr.vishalupadhyay@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr.B.L Kapur Memorial Hospital,Pusa Road,New Delhi, Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Dr B L Kapur Memorial Hospital |
| Address |
Dr.B.L Kapur Memorial Hospital,Pusa Road,New Delhi, Delhi 110005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Vishal Upadhyay |
Dr.B.L Kapur Memorial Hospital |
Department of Critical Care Medicine,Dr.B.L Kapur Memorial Hospital,Pusa Road,New Delhi, Delhi 110005
New Delhi
DELHI |
8447927104
dr.vishalupadhyay@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.B.L Kapur Memorial Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in Medical ICU with a suspected diagnosis of Sepsis and Septic Shock, with likely stay >72 hours. |
|
| ExclusionCriteria |
| Details |
1.Patients undergoing any emergency surgery.
2. Patients with a diagnosis of cancer or undergoing therapy for cancer.
3. Pregnant patients
4. Extremely critical patients: Refractory shock, Severe refractory metabolic acidosis
(pH<7.0), persistent hypoxemia (PaO2 (<50 mm Hg), Multiorgan failure on presentation (3
or more organ failures on presentation), APACHE II >35, SOFA>20. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prognostic value of Procalcitonin (PCT), C-Reactive Protein (CRP) and
Interleukin-6 (IL-6) in patients with sepsis and septic shock |
Day 1,Day 3,Day 7 and day 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess correlation Procalcitonin (PCT), C-Reactive Protein (CRP) and
Interleukin-6 (IL-6) with disease severity scoring systems- Acute
Physiology & Chronic Health Evaluation II (APACHE II) and Sequential
Organ Failure Assessment score (SOFA). |
The APACHE II score will be
collected once only after 24-hour of admission to ICU. SOFA scores of Day1, 3, 7 and 12 will be taken into consideration. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
07/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: A qualitative evaluation of PCT,CRP IL-6 for prognosis of sepsis and septic shock
Primary objective: Prognostic value of PCT,CRP and IL-6 in patients with sepsis and septic shock.
Secondary objective: To assess the correlation of PCT,CRP and IL-6 with disease severity scoring system- APACHE II and SOFA |