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NCT Number: NCT07698834

Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound

evaluation whether splanchnic Doppler ultrasound indices (SMA resistive index, portal vein pulsatility fraction, hepatic artery resistive index/flow parameters) can:

1. Reflect regional tissue perfusion in septic shock, as correlated with lactate clearance. 2. Associate with organ dysfunction severity and progression (SOFA dynamics). 3. Predict enteral feeding intolerance in ICU patients receiving enteral nutrition

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to severe organ dysfunction. Globally, sepsis accounts for approximately 48.9 million cases and 11 million deaths annually.

A central clinical challenge is hemodynamic incoherence, where systemic targets (e.g., mean arterial pressure [MAP]) may improve while regional tissue perfusion remains impaired. Conventional systemic markers, including blood lactate clearance and central venous oxygen saturation, reflect global metabolic status and may lag behind microvascular dysfunction within specific organ beds.

The hepatosplanchnic circulation is particularly vulnerable during septic shock and may contribute to progression toward multiple organ failure through a sustained inflammatory cascade. The splanchnic region has been described as the "motor" of multiple organ failure and the "canary" of the body.

Bedside Doppler ultrasound has emerged as a noninvasive tool to assess regional perfusion. Doppler-derived indices such as the resistive index (and related parameters including portal pulsatility fraction) may detect early hemodynamic impairment at the organ-bed level before systemic biomarkers change.

Accordingly, improved bedside perfusion monitoring especially for the splanchnic circulation-may help optimize resuscitation strategy and nutritional management, and may clarify relationships between regional perfusion, organ dysfunction, and enteral feeding tolerance.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Adult patients (≥18 years). 2. ICU admission with septic shock (Sepsis-3 definitions).

Exclusion criteria

  • 1. Advanced chronic liver disease. 2. Portal vein thrombosis. 3. Mesenteric ischemia (or clinical suspicion strongly suggesting it). 4. Severe right-sided heart failure. 5. Pregnancy. 6. Morbid obesity or any condition causing poor/unsafe ultrasound acoustic window.
  • Intra-abdominal conditions preventing adequate Doppler assessment. 8. Limitation of care / do-not-resuscitate orders. 9. Pre-existing major gastrointestinal bleeding/obstruction if that is relevant to enteral feeding intolerance outcomes in your ICU.

Treatment and study plan

Primary outcomes

  1. Association between portal vein PF and SOFA progression

    Time frame: baseline through 72 hours after ICU admission

    To evaluate the association between portal vein pulsatility fraction and progression in the Sequential Organ Failure Assessment (SOFA) score, defined as the difference between the baseline SOFA score and the SOFA score at 24 hours, or the peak SOFA score within 72 hours after ICU admission. The SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction and a worse clinical outcome.

  2. Lactate clearance (%) at 6 and 24 hours after ICU admission

    Time frame: baseline through 24 hours after ICU admission

    Lactate clearance, expressed as a percentage (%), calculated from serial arterial blood lactate concentrations measured at baseline, 6 hours, and 24 hours after ICU admission. Blood lactate concentration will be measured using standard arterial blood gas/laboratory analysis. The correlation between the baseline superior mesenteric artery (SMA) resistive index measured by Doppler ultrasound and lactate clearance at 6 and 24 hours will be evaluated.

  3. Incidence of enteral feeding intolerance within 72 hours after ICU admission

    Time frame: within 72 hours after ICU admission

    Incidence (%) of enteral feeding intolerance occurring within 72 hours after ICU admission, assessed according to predefined clinical criteria (e.g., vomiting, abdominal distension, or interruption of enteral nutrition due to intolerance). Superior mesenteric artery resistive index (SMA RI), portal vein pulsatility fraction (PVPF), and hepatic artery resistive index (HARI), measured by Doppler ultrasound at 24 hours after ICU admission, will be correlated with the occurrence of enteral feeding intolerance.

Secondary outcomes

  1. Length of ICU Stay

    Time frame: From ICU admission until ICU discharge

    Length of ICU stay, measured in days from ICU admission until ICU discharge. Splanchnic Doppler ultrasound parameters, including superior mesenteric artery resistive index (SMA RI), portal vein pulsatility fraction (PVPF), and hepatic artery resistive index (HARI), measured 24 hours after ICU admission, will be evaluated for their predictive value for ICU length of stay.

  2. Duration of Vasopressor Therapy

    Time frame: From ICU admission until discontinuation of vasopressor therapy

    Duration of vasopressor therapy, measured in days from ICU admission until permanent discontinuation of vasopressor support. Splanchnic Doppler ultrasound parameters, including superior mesenteric artery resistive index (SMA RI), portal vein pulsatility fraction (PVPF), and hepatic artery resistive index (HARI), measured 24 hours after ICU admission, will be evaluated for their predictive value for vasopressor therapy duration.

  3. ICU Mortality

    Time frame: From ICU admission until ICU discharge

    ICU mortality, reported as the percentage of participants who die during the ICU stay. Splanchnic Doppler ultrasound parameters, including superior mesenteric artery resistive index (SMA RI), portal vein pulsatility fraction (PVPF), and hepatic artery resistive index (HARI), measured 24 hours after ICU admission, will be evaluated for their predictive value for ICU mortality.

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Tarek Ahmed

CONTACT

[email protected]

+201004590619

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Splanchnic Perfusion Monitoring Using Doppler Ultrasound in Septic Shock Patients: Correlation With Lactate Clearance, Organ Dysfunction, and Enteral Feeding Intolerance

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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