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Clinical Trials/CTRI/2026/02/102756
CTRI/2026/02/102756Not yet recruitingNot Applicable

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.

Dr Mithun Kiran1 site in 1 country85 target enrollmentStarted: February 7, 2027Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
85
Locations
1

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients more than 18 years presenting to ED with suspected sepsis (fever or source of infection and SIRS criteria) requiring ICU or HDU admissions.

Exclusion Criteria

  • 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.

Investigators

Sponsor
Dr Mithun Kiran
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Mithun Kiran

Kasturba Medical College, Manipal

Study Sites (1)

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