| CTRI Number |
CTRI/2023/02/049572 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
EVALUATION OF PULSE OXYMETER PARAMETER TO PREDICT REQUIREMENT OF DRUGS TO INCREASE BLOOD PRESSURE IN PATIENTS WITH SEPSIS |
|
Scientific Title of Study
|
EVALUATION OF PERFUSION INDEX AS A PREDICTOR OF VASOPRESSOR REQUIREMENT IN PATIENTS WITH SEPSIS - A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
PerfPredict |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaydeep Narendrabhai Anadkat |
| Designation |
Registrar Critical Care Medicine |
| Affiliation |
Indraprastha Apollo Hospitals |
| Address |
Indraprastha Apollo Hospitals, Sarita Vihar,
Mathura road
North
DELHI
11076
India |
| Phone |
8866487547 |
| Fax |
|
| Email |
jaydeepanadkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Kansal |
| Designation |
Senior Consultant |
| Affiliation |
Indraprastha Apollo Hospitals |
| Address |
Dept of Respiratory and critical care medicine, Indraprastha Apollo Hospitals
Sarita Vihar, Mathura road
North
DELHI
110076
India |
| Phone |
9810399558 |
| Fax |
|
| Email |
kansalsudha08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaydeep Narendrabhai Anadkat |
| Designation |
Registrar Critical Care Medicine |
| Affiliation |
Indraprastha Apollo Hospitals |
| Address |
Indraprastha Apollo Hospitals, Sarita Vihar
Mathura road
North
DELHI
110076
India |
| Phone |
8866487547 |
| Fax |
|
| Email |
jaydeepanadkat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indraprastha Apollo Hospital, Mathura road, New Delhi 110076 - Institution |
|
|
Primary Sponsor
|
| Name |
Indraprastha Apollo Hospitals |
| Address |
Sarita Vihar, MAthura Road, New Delhi 110076 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Jaydeep Narendrabhai Anadkat |
Indraprastha Apollo Hospitals |
Department of critical care medicine(ICU & ER), GLMICU 2nd floor, Sarita Vihar, Mathura road, New Delhi 110076
South
DELHI |
8866487547
jaydeepanadkat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - BIOMEDICAL RESEARCH |
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 |
Age> 18 years
Clinically suspected sepsis
Adequate Fluid Resuscitation (30ml/kg) |
|
| ExclusionCriteria |
| Details |
Age < 18 years
Pregnant Females
inadequate fluid resuscitation (<30ml/kg)
Already receiving vasopressor therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare perfusion index to arterial lactate levels at T0 and T6 hours as predictor of vasopressor requirement in first 24 hour |
Compare perfusion index to arterial lactate levels at T0 and T6 hours as predictor of vasopressor requirement in first 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| final outcome of patients with sepsis (Discharged / Death) |
0-28 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/02/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will study patients with sepsis our pulse oxymeter derived parameter - perfusion index in observational manner as a prospective study at Indraprastha Apollo New Delhi. The patients will receive adequate fluid resuscitation (30 ml/kg) as part of sepsis treatment as per standard guidelines of care. After that perfusion index will be observed. At 6 hour interval , we will observe perfusion index again. We will follow these patients in course of stay and see for how many patients required vasopressor therapy in initial 24 hours (primary objective) and what was the outcome of patient (secondary objective). |