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Clinical Trials/CTRI/2022/10/046646
CTRI/2022/10/046646Not yet recruitingNot Applicable

Predicting 28-Day mortality in adult patients with sepsis or septic shock using combination of point of care tests including Procalcitonin, Lactate, NT-proBNP, and Diastolic dysfunction: A Prospective Observational Study

AIIMS JODHPUR1 site in 1 country144 target enrollmentStarted: October 31, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
144
Locations
1
Primary Endpoint
Predicting the outcome (28-day mortality) using combined score of procalcitonin, lactate, NT-pro BNP, and E/e’ in patients with sepsis and septic shock

Study Overview

Brief Summary

Several point of care biomarkers such asprocalcitonin, NT pro BNP, lactate etc. have been independently assessed fortheir association with outcome in sepsis. Also Diastolic dysfunction was found to beindependently, a major predictor of mortality in sepsis.

Therefore, we are planning a study topredict the short term (28 days) mortality in adult patients with sepsis orseptic shock using the combination of easily available point of care tests i.e procalcitonin, lactate, NT-pro BNP, and diastolicdysfunction assessed by transthoracic 2D-Echo.

We hypothesized thata combination of point of care test biomarkers and diastolic dysfunction usingE/e’ ratio could predict 28- day mortality in adultpatients with sepsis or septic shock with high sensitivity and specificity

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Diagnosis of Sepsis or septic shock (Sepsis -3 definition) in patients who are >18 years of age admitted to AICU.

Exclusion Criteria

  • •1.Patient refusal.
  • •2.Pregnant patients.
  • •3.Pre-existing impaired left ventricular function, myocardial infarction, valvular heart disease, cardiac arrythmias.
  • •4.Traumatic brain injury.
  • •5.Terminal stage of disease (Malignancy, Chronic Renal Failure, End stage liver disease).
  • •6.Poor Echo window.

Outcomes

Primary Outcomes

Predicting the outcome (28-day mortality) using combined score of procalcitonin, lactate, NT-pro BNP, and E/e’ in patients with sepsis and septic shock

Time Frame: biomarker measurement at admission

Secondary Outcomes

  • Comparing the ability of outcome prediction (28-day mortality) of each of four variable V/s SOFA score.
  • Comparing combined score V/s SOFA score for outcome prediction (28-day mortality).

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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