| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mithunkiran7@gmail.com].
- 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.
- 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. |