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CTRI Number  CTRI/2026/02/102756 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   A study to understand how blood flow and heart function affect recovery in patients with severe infection in the emergency department. 
Scientific Title of Study   PREDICT (Perfusion Restriction Evaluation with Doppler Indices, Cardiac output and Thermography): A study of Point of Care arterial doppler indices, Microcirculatory and Macro circulatory parameters and their association with clinical outcomes in patients with sepsis presenting to the Emergency Medicine department. 
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 Mithun Kiran 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Emergency Medicine Kasturba Medical College Manipal Academy of Health Education Manipal - 576104

Udupi
KARNATAKA
576104
India 
Phone  7975022731  
Fax    
Email  mithun.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayaraj Mymbilly Balakrishnan 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Emergency Medicine Kasturba Medical College Manipal Academy of Health Education Manipal - 576104

Udupi
KARNATAKA
576104
India 
Phone  9895063580  
Fax    
Email  jayaraj.mb@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Mithun Kiran 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Emergency Medicine Kasturba Medical College Manipal Academy of Health Education Manipal - 576104

Udupi
KARNATAKA
576104
India 
Phone  7975022731  
Fax    
Email  mithun.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Mithun Kiran 
Address  Department of Emergency Medicine Kasturba Medical College Manipal Academy of Health Education Manipal - 576104 
Type of Sponsor  Other [Self] 
 
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 Mithun Kiran  Kasturba Medical College, Manipal  Department of Emergency Medicine Kasturba Medical College Manipal Academy of Health Education Manipal - 576104
Udupi
KARNATAKA 
7975022731

mithun.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients more than 18 years presenting to ED with suspected sepsis (fever or source of infection and SIRS criteria) requiring ICU or HDU admissions. 
 
ExclusionCriteria 
Details  Patients in septic shock requiring more than 1 vasopressor or high dose vasopressor (Norepinephrine or Epinephrine more than 0.3 mcg per kg per min, Dopamine more than 15mcg per kg per min) at the time of recruitment.
Patients with ongoing major haemorrhage (GI bleed, intracranial bleed, massive haemoptysis, obstetric haemorrhage, trauma related bleeding.)
Bilateral femoral site vascular access.
Patients who are pregnant.
Suspected sepsis patients with an established alternate diagnosis during the course of stay in the hospital.
Patients with known peripheral vascular disease (PVD) will be excluded, as it may confound Doppler and thermography assessments of peripheral perfusion.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the association of point of care femoral, dorsalis pedis, aortic doppler indices and microcirculatory parameters (capillary refill time, plethysmography perfusion index, lactate and IR thermography mottling indices) along with macro circulatory parameters (heart rate, blood pressure, left ventricular outflow tract area, velocity-time integral, stroke volume) with 24 hours and 72 hours clinical outcomes in patients with suspected sepsis presenting to the Emergency Medicine Department.   Time of presentation,
24 hours, 72 hours, 1 week.  
 
Secondary Outcome  
Outcome  TimePoints 
To study the association of point of care femoral, dorsalis pedis, aortic doppler indices & microcirculatory parameters (capillary refill time, plethysmography perfusion index, lactate, & IR thermography mottling indices) with survival to discharge & length of ICU stay of the above study subjects.  At the time of presentation, 24 hours, 72 hours, one week.  
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   07/02/2027 
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   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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mithunkiran7@gmail.com].

  6. For how long will this data be available start date provided 07-02-2027 and end date provided 29-02-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

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

One of the leading causes of preventable deaths, especially in low- and middle- income countries is sepsis. Hence, early intervention in treating patients presenting to the Emergency Department with sepsis is crucial in improving patient outcomes. Traditionally, patients’ macro circulatory parameters such as mean arterial pressure (MAP) and heart rate are considered, which may not always reflect tissue perfusion. Patients can have normal blood pressure but may still be experiencing ongoing microcirculatory failure – cryptic shock. 

Recent studies indicate that microcirculatory dysfunction, indicated by impaired capillary refill time, high lactate levels, or changes in doppler indices, may precede hemodynamic failure and organ damage. Despite this, microcirculatory parameters are not commonly utilised in the emergency settings because of easily implementable technology, absence of standardised methods and lack of awareness. This study fills a significant gap by combining point-of-care ultrasound evaluations of microcirculation and overall circulation in the Emergency Department (ED), while linking them to clinical outcomes after 24 hours, 72 hours, and one week. These outcomes include the need for increased vasopressors, renal replacement therapy, and mortality rates. By establishing correlations and identifying the gaps, this research could improve predictions for sepsis and guide evidence-based triage decisions in EDs across the country.

 
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