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CTRI Number  CTRI/2023/08/057001 [Registered on: 28/08/2023] Trial Registered Prospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effect of secondary infections causing low blood pressure in ICU population 
Scientific Title of Study   Outcome of New Onset Septic Shock in ICU population  
Trial Acronym  ICU 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchika Jyoti 
Designation  DNB SS Critical Care Medicine 
Affiliation  Max Super Speciality Hospital, Saket 
Address  6th floor MICU,Critical Care Medicine Department, Max Super Speciality Hospital,1,2 Press Enclave Marg, Saket, New Delhi,110017

South
DELHI
110017
India 
Phone  9419236320  
Fax    
Email  ruchika_jyoti@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Deven Juneja 
Designation  Director Critical Care Medicine Department 
Affiliation  Max Super Speciality Hospital, Saket 
Address  6th floor MICU,Critical Care Medicine Department,Max Super Speciality Hospital,1,2 Press Enclave Marg, Saket, New Delhi, 110017

South
DELHI
110017
India 
Phone  9818290380  
Fax    
Email  deven_juneja@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ruchika Jyoti 
Designation  DNB SS Critical Care Medicine 
Affiliation  Max Super Speciality Hospital 
Address  6th floor MICU,Critical Care Medicine Department,Max Super Speciality Hospital , 1,2 Press Enclave Marg, Saket, New Delhi, 110017

South
DELHI
110017
India 
Phone  9419236320  
Fax    
Email  ruchika_jyoti@yahoo.in  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Max Super Speciality Hospital 
Address  Max Super Speciality Hospital, 1,2 press enclave marg, saket 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchika Jyoti  Max Super Speciality Hospital  Critical Care Medicine Department 1,2 Press Enclave Marg, Saket, New Delhi, 110017
New Delhi
DELHI 		 9419236320

ruchika_jyoti@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare Institutional Ethic Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B965||Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable   Not applicable  
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient admitted in Intensive care unit.
2. Developing septic shock after 48 hours of ICU admission.
3. Patients diagnosed with new onset septic shock according to sepsis 3 definition ( septic shock defined as suspected or confirmed infection plus hyperlactatemia ( more than 2 mmol per litre) and requirement of vasopressor to maintain a mean arterial pressure of 65 mmHg or higher after intravenous fluid resuscitation as per surviving sepsis guidelines - 2021). 
 
ExclusionCriteria 
Details  1. Patients below 18 years of age.
2. Patients developing shock within 48 hours of ICU admission.
3. Patients with End of life care. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality in ICU patients developing new onset septic shock  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Need & duration of vas opressors.   28 days 
Need of invasive mechanical ventilation & it’s duration  28 days 
Need of renal replacement therapy & it’s duration  28 days 
Source of infection   28 days 
ICU & hospital length of stay.  28 days 
Effect of timing of appropriate antibiotics on mortality  28 days 
Risk factors for 28 days mortality  28 days 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
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)   03/09/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This is a prospective observational study in which we aim to study the incidence, ICU course and outcome in terms of 28 days mortality. The primary outcome measures will be 28 days mortality in ICU patients developing new onset septic shock. The secondary  outcome will be need and duration for vasopressors, need and duration for renal replacement therapy, risk factors for 28 days mortality, source of infection, ICU and hospital length of stay. 
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