- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07698834
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
evaluation whether splanchnic Doppler ultrasound indices (SMA resistive index, portal vein pulsatility fraction, hepatic artery resistive index/flow parameters) can:
- Reflect regional tissue perfusion in septic shock, as correlated with lactate clearance.
- Associate with organ dysfunction severity and progression (SOFA dynamics).
- Predict enteral feeding intolerance in ICU patients receiving enteral nutrition
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Esraa Tarek Ahmed
- 전화번호: +201004590619
- 이메일: esraatarek062@Gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
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디자인 세부사항
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주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Association between portal vein PF and SOFA progression
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of ICU Stay
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- ] 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- splanchnic doppler in sepsis
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