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Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound

7. juli 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

80

Kontakter og plasseringer

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Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Association between portal vein PF and SOFA progression
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of ICU Stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • ] 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

2. juli 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

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