| CTRI Number |
CTRI/2019/12/022211 [Registered on: 02/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Fluid resuscitation and monitoring in the initial period of severe infection |
|
Scientific Title of Study
|
Hemodynamic resuscitation and monitoring in early sepsis - A multicentric observational study on practice patterns of hemodynamic resuscitation in septic shock |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT04143035 |
ClinicalTrials.gov |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil R |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college and Kasturba hospital Manipal |
| Address |
Department of critical care medicine, Kasturba medical college Manipal
Madhav Nagar,Manipal,Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8095800142 |
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil R |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college and Kasturba hospital Manipal |
| Address |
Department of critical care medicine, Kasturba medical college Manipal
Madhav Nagar,Manipal,Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8095800142 |
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil R |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college and Kasturba hospital Manipal |
| Address |
Department of critical care medicine, Kasturba medical college Manipal
Madhav Nagar,Manipal,Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8095800142 |
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian society of critical care medicine |
|
|
Primary Sponsor
|
| Name |
Indian society of critical care medicine |
| Address |
6, Hind Service Ind. Premises, Dadar, Mumbai, Maharashtra 400028 |
| Type of Sponsor |
Other [society of critical care medicine in India] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sunil R |
Department of critical care medicine Kasturba medical college Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil R |
Kasturba medical college and hospital |
ICU 1 & 2 complex,first floor,casualty and trauma block,Kasturba hospital, Madhav nagar, Manipal 576104
Udupi
KARNATAKA |
8095800142
sunil.r@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
any patient admitted with septic shock not maintaining mean arterial pressure of 65 mm Hg without vasopressors |
|
| ExclusionCriteria |
| Details |
cardiogenic/obstructive/hemorrhagic shock
do not resuscitate/do not intubate patients
admission from other ICU/hospital with more than 7 days stay in that ICU/hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Completing the elements of the one hour SSC sepsis bundle in one 1 hour |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hospital mortality/28-day mortality whichever is earlier
Completing the elements of the one hour SSC sepsis bundle in one three hour |
28 day mortality
SSC bundle in three hours |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
02/12/2019 |
| 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="0"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a multi centric observational single arm cohort study. The purpose of the study is to monitor the fluid resuscitation practice in the initial period of sepsis and the various monitoring technique involved in various ICUs across India. It also analyses the 28 day mortality resulted from the different resuscitation practices done during the study period. |