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Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07698834
Enrollment
80
Registered
2026-07-13
Start date
2026-09-01
Completion date
2027-10-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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. 7\. 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.

Design outcomes

Primary

MeasureTime frameDescription
Association between portal vein PF and SOFA progressionbaseline through 72 hours after ICU admissionTo 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.
Lactate clearance (%) at 6 and 24 hours after ICU admissionbaseline through 24 hours after ICU admissionLactate 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.
Incidence of enteral feeding intolerance within 72 hours after ICU admissionwithin 72 hours after ICU admissionIncidence (%) 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

MeasureTime frameDescription
Length of ICU StayFrom ICU admission until ICU dischargeLength 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.
Duration of Vasopressor TherapyFrom ICU admission until discontinuation of vasopressor therapyDuration 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.
ICU MortalityFrom ICU admission until ICU dischargeICU 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.

Contacts

CONTACTEsraa Tarek Ahmed
esraatarek062@Gmail.com+201004590619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026