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Clinical Trials/CTRI/2025/08/092165
CTRI/2025/08/092165
Not yet recruiting
Not Applicable

Correlation between Corrected Carotid Flow Time and Left Ventricular Outflow Tract Velocity-Time Integral using Trans-Thoracic Echocardiography for assessing Fluid Responsiveness in septic shock patients admitted to ICU : A Prospective observational Study

AIIMS PATNA1 site in 1 country52 target enrollmentStarted: August 14, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
AIIMS PATNA
Enrollment
52
Locations
1
Primary Endpoint
LVOT-VTI

Overview

Brief Summary

Selecting an efficient method to assess Fluid responsiveness in ICU is crucial

especially in first one hour of presentation in septic shock patients. Prompt

administration of fluid during early resuscitation phase might prove to be an important

factor in further prognosis of the patient. According to Recent Surviving Sepsis

Guidelines, the second pillar of treatment is fluid resuscitation.

Rationale

Trans-Thoracic Echocardiography (TTE) is widely used in ICU for assessing fluid

responsiveness. The left ventricular outflow tract velocity time integral (LVOT VTI)

shows how the SV changes in response to fluid administration; therefore, the LVOT

VTI is used to guide intravenous fluid management. However, Common Carotid

Artery Flow Doppler is much easier, does not depend on adequate cardiac windows,

and requires less skill and expertise than LVOT VTI.

Study Procedure

Transthoracic Echocardiography will be done to assess LVOT VTI initially and 20 minutes after fluid administration.  Corrected Carotid Flow Time (cCFT) will also be calculated similarly at these two time points. Fluid responsiveness will be defined if LVOT VTI is more than 17 cm or Delta VTI is less than 15 percent, and corresponding cCFT value will be taken for correlation with LVOT VTI

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients in Septic Shock as per recent surviving sepsis guidelines (SSG 2021).

Exclusion Criteria

  • Age less than 18 and more than
  • Poor quality of ultrasonographic imaging.
  • Inability to achieve a zero degree angulation of the pulsed Doppler signal for assessing LVOT or carotid flow, LVOT dynamic obstruction, cardiac arrhythmia.
  • Significant aortic valve disease (stenosis and/or moderate to severe insufficiency) significant carotid disease (stenosis greater than 50%) Intracranial hypertension cerebral circulatory arrest, aortic dissection, ischemic heart disease, heart failure, and hypertensive crisis requiring vasoactive drugs.

Outcomes

Primary Outcomes

LVOT-VTI

Time Frame: Baseline and after 20 minutes of Fluid Administration

Corrected Carotid Flow Time

Time Frame: Baseline and after 20 minutes of Fluid Administration

Delta VTI

Time Frame: Baseline and after 20 minutes of Fluid Administration

Stroke volume variation

Time Frame: Baseline and after 20 minutes of Fluid Administration

Secondary Outcomes

  • Duration on Mechanical Ventilator(Duration on Ionotropic Support)

Investigators

Sponsor
AIIMS PATNA
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Mainak Baidya

AIIMS PATNA

Study Sites (1)

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