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Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound

7 luglio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

80

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Association between portal vein PF and SOFA progression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Length of ICU Stay
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • ] 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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • splanchnic doppler in sepsis

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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