| CTRI Number |
CTRI/2024/10/076007 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Observational study to predict the impact of proposed fluid score on organ dysfunction in a population of patients with infection. |
|
Scientific Title of Study
|
Pocus based fluid tolerance score as a predictor of end organ dysfunction and mortality in patients with sepsis- a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 3.0 dated 10/06/2024 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arshad N N |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
Narayana Health |
| Address |
Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra
Bangalore
KARNATAKA
560099
India |
| Phone |
8281483704 |
| Fax |
|
| Email |
arshadnadirsha07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Bhardwaj |
| Designation |
Consultant, Critical Care Medicine |
| Affiliation |
Narayana Health |
| Address |
258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9686124830 |
| Fax |
|
| Email |
vmlbhardwaj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimal Bhardwaj |
| Designation |
Consultant, Critical Care Medicine |
| Affiliation |
Narayana Health |
| Address |
258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area, Bengaluru
KARNATAKA
560099
India |
| Phone |
9686124830 |
| Fax |
|
| Email |
vmlbhardwaj@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru ,India , 560099 |
|
|
Primary Sponsor
|
| Name |
Dr Arshad N N |
| Address |
Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru |
| Type of Sponsor |
Other [Self] |
|
|
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 Arshad N N |
Mazumdar Shaw Medical Centre |
Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru
Bangalore
KARNATAKA |
8281483704
arshadnadirsha07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic 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
|
| 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 |
Patients aged above 18 years, admitted to MICU with sepsis/septic shock
|
|
| ExclusionCriteria |
| Details |
1. Severe MR, AR
2. Pregnancy
3. Prosthetic, transplant heart |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate pocus based fluid tolerance score with end organ dysfunction and mortality
in septic shock patients. |
Baseline, every 48 hours until ICU discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the incidence of organ dysfunction in adult septic patients with systemic venous congestion.
|
Baseline, every 48 hours until ICU discharge |
|
|
Target Sample Size
|
Total Sample Size="149"
Sample Size from India="149"
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)
|
11/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Excessive fluid resuscitation in septic shock causes venous congestion, that in turn contribute to poor clinical outcome and end organ dysfunction. So the focus of attention has to be changed from forward flow assessment (cardiac output and microcirculatory parameters) to venous congestion assessment and organ function.
Concept of fluid tolerance will help to bridge the gap between fluid responsiveness and fluid overload. POCUS based parameters will be able to pick up early signs of venous congestion that lead to fluid intolerance. There is lacunae in literature to correlate the relationship of fluid tolerance and their relation to end organ dysfunction.
Hence a pocus parameters based fluid tolerance score has been constructed and we are analyzing correlation between this fluid tolerance score with end organ dysfunction and mortality in septic shock patients. |