Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound

July 7, 2026 updated by: Esraa Tarek Mahmoud Ahmed, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline through 72 hours after ICU admission
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.
baseline through 24 hours after ICU admission
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.
within 72 hours after ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From ICU admission until ICU discharge
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.
From ICU admission until discontinuation of vasopressor therapy
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.
From ICU admission until ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • ] Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS. The third international consensus definitions for sepsis and septic shock (Sepsis-3). Jama. 2016 Feb 23;315(8):801-10. [2] Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. The Lancet. 2020 Jan 18;395(10219):200-11. [3] Markwart R, Saito H, Harder T, Tomczyk S, Cassini A, Fleischmann-Struzek C, Reichert F, Eckmanns T, Allegranzi B. Epidemiology and burden of sepsis acquired in hospitals and intensive care units: a systematic review and meta-analysis. Intensive care medicine. 2020 Aug;46(8):1536-51. [4] Ince C. Hemodynamic coherence and the rationale for monitoring the microcirculation. Critical care. 2015 Dec 18;19(Suppl 3):S8. [5] Hariri G, Joffre J, Leblanc G, Bonsey M, Lavillegrand JR, Urbina T, Guidet B, Maury E, Bakker J, Ait-Oufella H. Narrative review: clinical assessment of peripheral tissue perfusion in septic shock. Annals of intensive care. 2019 Mar 13;9(1):37. [6] Huber W, Zanner R, Schneider G, Schmid R, Lahmer T. Assessment of regional perfusion and organ function: less and non-invasive techniques. Frontiers in medicine. 2019 Mar 22;6:50. [7] Asfar P, De Backer D, Meier-Hellmann A, Radermacher P, Sakka SG. Clinical review: influence of vasoactive and other therapies on intestinal and hepatic circulations in patients with septic shock. Critical care. 2003 Jun;8(3):170. [8] Dr D. The gastrointestinal tract. The canary of the body?. JAMA. 1993;270:1247-8. [9] Tavazzi G, Spiegel R, Rola P, Price S, Corradi F, Hockstein M. Multiorgan evaluation of perfusion and congestion using ultrasound in patients with shock. European Heart Journal: Acute Cardiovascular Care. 2023 May 4;12(5):344-52. [10] Buitr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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