| CTRI Number |
CTRI/2024/09/073790 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating Diastolic Shock Index Trends and Clinical Outcomes in Indian Patients with Septic Shock: A Prospective Study |
|
Scientific Title of Study
|
Temporal analysis of Diastolic Shock Index in patients with Septic Shock and its correlation with clinical outcomes
in Indian setting- a prospective observational study. |
| 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 Afzal Azim |
| Designation |
Professor Critical Care Medicine |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow |
| Address |
Department of Critical Care Medicine, Sanjay Gandhi Postgraduate
Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9984988393 |
| Fax |
|
| Email |
draazim2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Sarkar |
| Designation |
DM Senior Resident |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow |
| Address |
Department of Critical Care Medicine, Sanjay Gandhi Postgraduate
Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9810620305 |
| Fax |
|
| Email |
sarkar.soumya03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Sarkar |
| Designation |
DM Senior Resident |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow |
| Address |
Department of Critical Care Medicine, Sanjay Gandhi Postgraduate
Institute of Medical Sciences, Raebareli Road, Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9810620305 |
| Fax |
|
| Email |
sarkar.soumya03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh, India Pin-226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow |
| Address |
Department of Critical Care Medicine, Sanjay Gandhi Postgraduate
Institute of Medical Sciences, Raebareli Road, Lucknow-226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Afzal Azim |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
1st Floor, F block, Department of Critical Care Medicine, Sanjay Gandhi Postgraduate institute of medical sciences, Lucknow, Uttar Pradesh, India PIN-226014
Lucknow
UTTAR PRADESH |
9984988393
draazim2002@gmail.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, |
|
|
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 |
Patients above the age of 18 years
Diagnosed with septic shock according to the Third International Consensus Definitions
for Sepsis and Septic Shock (Sepsis-3)
Patients/ guardians giving informed and written consent for the same |
|
| ExclusionCriteria |
| Details |
Pregnant women
Shock caused due to other causes
Acute/ chronic atrial fibrillation, presence of ventricular arrhythmia, use of
definitive/transitory pacemaker, presence of valvular heart disease
Recordings from intra-arterial catheter placed at sites other than radial and femoral artery
Patients/guardians refusing consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality outcome in ICU |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation with ICU severity scores
Number of vasopressor free days
Duration of mechanical ventilation free days
Renal replacement therapy free days
Length of icu stay |
28 days |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
16/09/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Summary: Septic shock at the end of continuous spectrum of sepsis, is a life threatening condition accounting for high mortality in patients getting admitted in intensive care units. Early detection and prompt intervention is one of the goals of effective therapy in management of septic shock. Diastolic blood pressure, the minimum pressure in the aorta that is during the diastolic period of the cardiac cycle. Diastolic shock index has been implicated as a surrogate to the state of the vascular tone. Ospina tascón et al in 2020 studied the diastolic shock index and its clinical outcomes in septic shock patients. They concluded that DSI can serve as an early indicator of high mortality risk in septic shock patients. Prospective studies regarding diastolic shock index and its correlation to clinical outcomes are lacking. So in this prospective observational study on adult septic shock patients, we aim to analyze the temporal trends of Diastolic Shock Index and its correlation with clinical outcomes. We will also compare the other hemodynamic indices such as shock index, modified shock index, lactate, VIS score and their prognostic performance. |