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

NCT07653568 | Active Not Recruiting

• 1 other identifier: 20-4/AS&RB-M/SZAMU/2025-2378
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid Responsiveness Predictability in Sepsis

Keywords

Fluid responsiveness; LVOT; Common carotid artery blood flow; Sepsis; TTE-CO; Carotid doppler; Ventilated patients

Outcome Measures

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.

  Peri-Procedural

Study Arms (1)

Mechanically ventilated septic patients undergoing fluid responsiveness assessment

EXPERIMENTAL

Participants enrolled in this study arm will undergo non-invasive bedside hemodynamic evaluation during passive leg raising. Doppler ultrasound of the common carotid artery and transthoracic echocardiographic assessment of cardiac output will be performed at predefined stages of assessment to examine circulatory changes associated with preload variation. Intravenous crystalloid administration may be provided when study-defined indicators of preload responsiveness are observed, followed by reassessment using the same ultrasound-based methods.

Drug: intravenous crystalloid fluid bolus

Interventions

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.

Mechanically ventilated septic patients undergoing fluid responsiveness assessment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with sepsis requiring mechanical ventilation in the intensive care unit
• Patients requiring fluid assessment or fluid resuscitation based on clinical findings, including one or more of the following:
• Heart rate greater than 100 beats per minute
• Systolic blood pressure less than 90 mmHg
• Mean arterial pressure less than 65 mmHg
• Urine output less than 0.5 mL/kg/hour for at least 2 hours

You may not qualify if:

• 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
• Significant valvular heart disease
• Status asthmaticus
• Pulmonary hypertension
• Pulmonary embolism
• Pregnancy
• Lower limb conditions preventing passive leg raising, including fractures
• Intra-abdominal hypertension
• Recent abdominal surgery
• Known carotid artery disease or common carotid artery stenosis greater than 50%

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Pakistan Institute Of Medical Sciences

Islamabad, Federal Area, 44000, Pakistan

Location

Related Publications (1)

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.

  PMID: 34605781 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rana Imran SIkander, MBBS, MCPS, FCPS

  Pakista Institute of Medical Sciences

  STUDY CHAIR

• Syed Muneeb Ali, MBBS, MCCM, MD CCM

  Pakistan Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT CRITICAL CARE MEDICINE

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 29, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

PA (1)