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Clinical Trials/CTRI/2024/09/073790
CTRI/2024/09/073790RecruitingNot Applicable

Temporal analysis of Diastolic Shock Index in patients with Septic Shock and its correlation with clinical outcomes in Indian setting- a prospective observational study.

Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow1 site in 1 country97 target enrollmentStarted: September 16, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
97
Locations
1
Primary Endpoint
Mortality outcome in ICU

Study Overview

Brief Summary

Summary: Septic shock at the end of continuous spectrum of sepsis, is a life threatening condition accounting for high mortality in patients getting admitted in intensive care units. Early detection and prompt intervention is one of the goals of effective therapy in management of septic shock.

Diastolic blood pressure, the minimum pressure in the aorta that is during the diastolic period of the cardiac cycle. Diastolic shock index has been implicated as a surrogate to the state of the vascular tone. Ospina tascón et al in 2020 studied the diastolic shock index and its clinical outcomes in septic shock patients. They concluded that DSI can serve as an early indicator of high mortality risk in septic shock patients. Prospective studies regarding diastolic shock index and its correlation to clinical outcomes are lacking. So in this prospective observational study on adult septic shock

patients, we aim to analyze the temporal trends of Diastolic Shock Index and its correlation with clinical outcomes. We will also compare the other hemodynamic indices such as shock index, modified shock index, lactate, VIS score and their prognostic performance.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients above the age of 18 years Diagnosed with septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) Patients/ guardians giving informed and written consent for the same.

Exclusion Criteria

  • Pregnant women Shock caused due to other causes Acute/ chronic atrial fibrillation, presence of ventricular arrhythmia, use of definitive/transitory pacemaker, presence of valvular heart disease Recordings from intra-arterial catheter placed at sites other than radial and femoral artery Patients/guardians refusing consent.

Outcomes

Primary Outcomes

Mortality outcome in ICU

Time Frame: 28 days

Secondary Outcomes

  • Correlation with ICU severity scores(Number of vasopressor free days)

Investigators

Sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Afzal Azim

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow

Study Sites (1)

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