A Study Comparing Carotid Doppler Ultrasound and Echocardiography to Assess Fluid Responsiveness in Septic Patients on Ventilator

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorPakistan Institute of Medical Sciences

About this trial

The goal of this clinical trial is to determine whether common carotid artery blood flow measured by bedside Doppler ultrasound can accurately identify fluid responsiveness in mechanically ventilated adults with sepsis. The study will compare this method with transthoracic echocardiography-derived cardiac output, which is a commonly used non-invasive technique for assessing hemodynamic status in critically ill patients. The study also aims to evaluate whether carotid artery ultrasound can provide a faster and more practical bedside assessment during fluid resuscitation in the intensive care unit.

In patients with sepsis, giving too little intravenous fluid may worsen organ perfusion and shock, while excessive fluid administration may lead to complications such as pulmonary edema, worsening oxygenation, prolonged mechanical ventilation, and longer intensive care unit stay. Because of this, clinicians need reliable methods to identify which patients are likely to benefit from fluid administration. This concept is known as fluid responsiveness.

The main questions this study aims to answer are:

* Can common carotid artery blood flow measured by ultrasound predict fluid responsiveness as accurately as transthoracic echocardiography-derived cardiac output? * How closely do changes in carotid artery blood flow correspond to changes in cardiac output during passive leg raising? * Can carotid ultrasound provide a quicker and simpler bedside method for assessing fluid responsiveness in critically ill patients receiving mechanical ventilation? Researchers will compare two ultrasound-based methods during a passive leg raising test. Passive leg raising is a temporary bedside maneuver used to simulate a fluid challenge without immediately giving intravenous fluids. During this maneuver, the patient's legs are elevated while the upper body is lowered, allowing blood from the lower limbs to temporarily return to the central circulation. This increases blood flow to the heart and may increase cardiac output in patients who are likely to respond to fluid administration.

The study team will first record baseline measurements of common carotid artery blood flow and transthoracic echocardiographic cardiac output while the patient is in a semi-recumbent position. The passive leg raising maneuver will then be performed, and both measurements will be repeated to evaluate changes in blood flow and cardiac output. If the predefined criteria for fluid responsiveness are met, the participant will receive intravenous crystalloid fluid according to the study protocol.

Participants will:

* Undergo bedside Doppler ultrasound measurement of common carotid artery blood flow * Undergo transthoracic echocardiography to measure cardiac output * Have ultrasound measurements recorded before and after passive leg raising * Receive intravenous fluid administration if fluid responsiveness criteria are met * Continue routine monitoring of blood pressure, heart rate, oxygenation, urine output, and other intensive care parameters during the study period The findings from this study may help determine whether carotid artery ultrasound can be used as a practical bedside tool for fluid assessment in mechanically ventilated patients with sepsis, particularly in settings where rapid and non-invasive monitoring is needed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Adults with sepsis requiring mechanical ventilation in the intensive care unit

Heart rate greater than 100 beats per minute

Systolic blood pressure less than 90 mmHg

Mean arterial pressure less than 65 mmHg

Disqualifiers

Intracranial pathology associated with raised intracranial pressure, including intracerebral hemorrhage or space-occupying lesions

Recent neurosurgical procedures or conditions where passive leg raising may increase intracranial pressure

Known heart failure

Significant cardiac arrhythmias

Trial design

Design model

Single group

Treatments tested in this trial

  • intravenous crystalloid fluid bolus

    Drug

    Intravenous isotonic crystalloid solution will be administered to participants who demonstrate predefined indicators of fluid responsiveness during hemodynamic assessment. A 500 mL fluid bolus will be infused according to intensive care unit protocol following passive leg raising-associated circulatory changes identified by ultrasound-based monitoring methods. Hemodynamic reassessment will be performed after fluid administration to evaluate changes in circulatory parameters.

Treatment groups

94 Participants
are divided into 1 treatment group
Group A: Mechanically ventilated septic patients undergoing fluid responsiveness assessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic Accuracy of Common Carotid Artery Blood Flow- Cardiac Output in predicting fluid responsiveness.

This outcome will evaluate the ability of Doppler-derived common carotid artery blood flow measurements to identify fluid responsiveness in mechanically ventilated adults with sepsis using transthoracic echocardiography-derived cardiac output as the reference method. Diagnostic performance will be assessed through sensitivity, specificity, predictive values, overall accuracy, and agreement analysis during passive leg raising assessment.

Time frame
Peri-Procedural

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.