Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound
ConditionSeptic Shock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Adult patients (≥18 years). 2. ICU admission with septic shock (Sepsis-3 definitions).
Disqualifiers
None
Trial population
Adult patients (≥18 years) admitted to the ICU with septic shock according to Sepsis-3 criteria, who are eligible for enrollment and undergo splanchnic Doppler ultrasound evaluation 24 hours after ICU admission.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Association between portal vein PF and SOFA progression
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.
Time frame
baseline through 72 hours after ICU admission2
Lactate clearance (%) at 6 and 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.
Time frame
baseline through 24 hours after ICU admission3
Incidence of enteral feeding intolerance 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.
Time frame
within 72 hours after ICU admissionSecondary outcomes
1
Length of ICU Stay
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.
Time frame
From ICU admission until ICU discharge2
Duration 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.
Time frame
From ICU admission until discontinuation of vasopressor therapy3
ICU Mortality
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.
Time frame
From ICU admission until ICU dischargeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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