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CTRI Number  CTRI/2024/11/076532 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 16/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Peripheral Perfusion Index as a Predictor of Hypotension and Mortality in Sepsis 
Scientific Title of Study   An observational study to correlate peripheral perfusion index as a predictor of hypotension and mortality in sepsis patients 
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 RAJ BAHADUR SINGH 
Designation  Associate Professor 
Affiliation  IGIMS,Patna 
Address  Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna
Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  07897844636  
Fax    
Email  virgodocraj36@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR RAJ BAHADUR SINGH 
Designation  Associate Professor 
Affiliation  IGIMS,Patna 
Address  Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna
Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  07897844636  
Fax    
Email  virgodocraj36@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR RAJ BAHADUR SINGH 
Designation  Associate Professor 
Affiliation  IGIMS,Patna 
Address  Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna
Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  07897844636  
Fax    
Email  virgodocraj36@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna Bihar,India, 800014 
 
Primary Sponsor  
Name  IGIMSPATNA 
Address  Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna Bihar,India, 800014 
Type of Sponsor  Government medical college 
 
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 Raj Bahadur Singh  IGIMS,Patna  Department of Anaesthesiology [ Trauma and Emergency] IGIMS, Sheikhpura, Patna Bihar,India, 800014
Patna
BIHAR 		 07897844636

virgodocraj36@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IGIMS,PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I959||Hypotension, unspecified, (2) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The study selected consecutive adult patients admitted with the diagnosis of septic shock or within 24 h after septic shock onset in patients previously admitted for other causes. According to internationally accepted consensus definitions at the time of beginning of study , sepsis will be defined based on clinical evidence of infection and two or more of the following: fever axial temperature greater than 38°C or hypothermia axial temperature LESS THAN 36°C, tachycardia heart rate more than 90 beats per min, tachypnea more than 20 breaths per minute or need for mechanical ventilation, leukocytosis m ore than 12 000 cells/mm3 or leukopenia less than 4,000 cells/mm3, or a ratio of greater than 10% band cells to polymorphonuclear cells. Septic shock will be defined as sepsis with hypotension (mean arterial pressure less than 65 mm Hg and/or hypoperfusion represented by hyperlactatemia more than 2.0 mmol/L, irrespective of blood pressure, even after initial volume expansion and requiring vasopressors.. 
 
ExclusionCriteria 
Details  Other causes of shock,severe hepatopathy or coagulopathy platelets less than or equal to 20,000/mm3,international normalizated ratio more than 2.0, or activated partial thromboplastin time- aPTT more than 70 s, infective endocarditis, systemic sclerosis, and severe obstructive arterial disease. These criteria will be chosen to reduce the risks of possible hemorrhagic and ischemic complications of procedures. Patients with cardiac arrhythmias or active or severe bleeding will be also excluded from the protocol for assessing adrenergic stimulus that is increase of vasopressors doses. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To investigate the application of peripheral perfusion index (PPI) in early diagnosis and goal-directed therapy of septic shock, and to provide reference for the early clinical diagnosis and treatment of septic shock.  • At the time of admission
then every 6 hourly for first 24 hour then weekly and at last 28 days mortality benifit 
 
Secondary Outcome  
Outcome  TimePoints 
early treatment for sepsis and mortality benefit  patients admitted with the diagnosis of septic shock or within 24 h after septic shock onset in patients previously admitted for other causes. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   20/11/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [virgodocraj36@yahoo.co.in].

  6. For how long will this data be available start date provided 20-11-2024 and end date provided 20-11-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

OBJECTIVES

 

 

•       To investigate the application of peripheral perfusion index (PPI) in early diagnosis and goal-directed therapy of septic shock, and to provide reference for the early clinical diagnosis and treatment of septic shock.

MATERIAL AND METHODS

•       Type of Study :  Prospective Observational Study

•       Place of study :  Department of Trauma and Emergency

                                        Indira Gandhi Institute Of Medical Sciences,Sheikhpura Patna

 

•       Period of Study:   2 month

•        Approval from the ethical committee was obtained .

•       Adult patients with sepsis admitted to Trauma & Emergency department’s intensive care unit (ICU).

•       Group 1 – The PPI group will be defined using PPI < 1.4 as diagnosis of septic shock standard, and PPI > 2 as treatment guide target.

•       Group 2 – Control group. Control group will be defined according to the traditional diagnostic criteria of shock which systolic blood pressure will be less than 90 mmHg (1 mmHg = 0.133 kPa) or systolic blood pressure value decrease > 40 mmHg baseline and bundle treatment will be performed. 

The volume of fluid resuscitation, organ dysfunction, the sequential organ failure score (SOFA), acute physiology and chronic health evaluation II (APACHE II) score, continuous renal replacement therapy (CRRT) time, mechanical ventilation (MV) time, the length of ICU stay and 28-day mortality will be observed.

 
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