| CTRI Number |
CTRI/2019/10/021726 [Registered on: 21/10/2019] Trial Registered Prospectively |
| Last Modified On: |
18/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to capture the patient characteristics, practices of treatment and observation measures used to maintain the blood pressure in patient presenting with early infection and low blood pressure. |
|
Scientific Title of Study
|
Hemodynamic resuscitation and monitoring in early sepsis(HERMES Study) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol_No_3364_Version_1.0 dated 09 July 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and pain, Main Building, Dr.E Borges Road,Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and pain, Main Building, Dr.E Borges Road,Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and pain, Main Building, Dr.E Borges Road,Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Society of Critical Care Medicine
Unit 13-14,1st Floor,Hind Service Indus Premises Co.op Soc.Off VeerSavarkar Marg,Dadar,Mumbai-400028 |
|
|
Primary Sponsor
|
| Name |
Indian Society of Critical Care Medicine |
| Address |
Unit 13-14,1st Floor,Hind Service Indus Premises Co.op Soc.Off VeerSavarkar Marg,Dadar,Mumbai-400028
|
| Type of Sponsor |
Other [non-profit association of Indian Physicians, Nurses,& allied health care professionals] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Memorial Hospital |
Dr.E Borges Road, Parel, Mumbai-12 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSheila Nainan Myatra |
Tata Memorial Hospital |
Room no MB-117 and MB-217, Intensive care units,Main Building Department of Anesthesiology Critical care and Pain,Dr.E Borges road, Parel, Mumabi
Mumbai
MAHARASHTRA |
9820156070
sheila150@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, (2) ICD-10 Condition: R579||Shock, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (≥ 18 years old)
2. Presenting to ICU with suspected sepsis
3. Presence of hypotension (Systolic BP ≤ 90 mmHg / Mean arterial pressure (MAP) ≤ 65mmhg or patient with Systolic BP > 90 mmHg / MAP >65mmHg on vasopressor |
|
| ExclusionCriteria |
| Details |
1. Patient likely to be in shock due to reason other than sepsis (e.g. cardiogenic, hemorrhagic shock etc.)
2. Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission
3. Patient transferred from another hospital admitted for more than 7days
4. Patient transferred from another ICU |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.ICU Mortality
2.Sepsis resuscitation goals achieved in 1 hour |
Once after completion of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hospital mortality |
Once after completion of study. |
| 28-day mortality |
Once after completion of study. |
| Sepsis resuscitation goals achieved in 3 hour |
Once after completion of study. |
| Sepsis resuscitation goals achieved in 6 hour |
Once after completion of study |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
30/10/2019 |
| 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="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)?
|
|
Brief Summary
|
“Hemodynamic Resuscitation and Monitoring in Early
Sepsis (HERMES Study)†involves recording of patient’s
medical data related to that has been collected as part of his/her routine
medical care in ICU.
Presently
there is no data from Indian ICUs on the way patients in early sepsis are
resuscitated and monitored. There may exist a wide variation in clinical
practice. We would like to conduct an observational study in various levels of
Indian ICUs, to prospectively collect data on adult patients admitted to ICU
with early sepsis in a 60-day window period. We would like to study the
hemodynamic resuscitation and monitoring performed in these patients. In
addition, we would like to identify factors associated with improved outcomes
and achieving the goals of the sepsis bundles in one, three and six hours.
The objectives of the study are as follows
- To
capture the patient characteristics and hemodynamic resuscitation and
monitoring practices in patients presenting with early sepsis and
hypotension to Indian ICUs
- To
determine various factors associated with improved survival in patients
with septic shock
- To
determine factors associated with achieving the resuscitation goals of the
sepsis bundle within1 hour, 3 hours and 6 hours in patients with septic
shock
We plan to
recruit 50 -100 centers nationwide. Each center will be asked to collect data
from at least 10 patients in a maximum time window of 60 days. A convenience
sample of minimum 500 patients presenting to ICU with suspected sepsis and
hypotension will be taken.
Each
center will select a start date anytime between 1 st August to 1st October 2019
and will collect data within 60 days of the start date. The study will end
anytime between 30th September and 29th November 2019, depending on the start
date. All consecutive patients in the 60-day period will be screened and those
eligible will be enrolled.
There will
be no direct patient contact or intervention. Local coordinators will guarantee
the integrity of data collection and ensure timely completion of CRFs.
This is an ISCCM Research Committee funded
study. The ISCCM will fund the PI institution for all expenses related software
development, website hosting, secretarial assistance and miscellaneous expenses
related to the conduct of the study, data analysis and publication (against
actual bills). No funding will be given to the investigators from the various
participating centres for contributing data. |