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Набор скоро начнётся NCT06696391

Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

Фаза III С лечением Septic Shock Sepsis Shock Critical Care, Intensive Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Venous Excess Ultrasound (VEXUS)-Guided Management.
Кому может быть актуально
Состояния в реестре: Septic Shock, Sepsis, Shock, Critical Care, Intensive Care. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial

Обзор

The goal of this pilot clinical trial is to determine if conducting a larger study using venous excess ultrasound (VEXUS) to guide fluid management in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure. While fluids are essential for treatment, too much fluid can harm the kidneys and result in the need for dialysis. The main questions it aims to answer are: 1. Is it feasible to recruit patients, obtain consent, and follow the VEXUS-guided management protocol? 2. Does VEXUS-guided management, compared with usual care, improve the health and well-being of patients with septic shock? Researchers will compare two groups: one receiving VEXUS-guided fluid management versus another receiving standard care, to assess the feasibility of a larger trial and explore whether VEXUS prevents fluid overload and kidney problems. Participants in the VEXUS group will: 1. Undergo VEXUS scans every 24 hours for 3 days 2. Receive fluid management guided by VEXUS findings (including fluid restriction or removal if we identify venous congestion) and undergo cardiac ultrasound if we identify moderate to severe congestion 3. Be monitored for 28 days to track kidney function, need for dialysis, and survival.

Вмешательства

  • Другое Venous Excess Ultrasound (VEXUS)-Guided Management
    Expert operators will perform VEXUS within 6 hours of randomization and repeat the assessment every 24 hours for 3 days, or until ICU discharge or death. After each assessment, investigators will grade the severity of venous congestion using a modified version of the VEXUS score and provide updated management recommendations. Patients without congestion will receive standard fluid management. For mild congestion, investigators will implement fluid restriction (e.g., minimizing maintenance fluid

Первичные конечные точки

  • Recruitment Rate [Срок оценки: Up to 160 weeks]
Вторичные конечные точки (3)
  • Consent rate [Срок оценки: From enrollment to the end of the study period at 28 days]
  • VEXUS scan completion rate [Срок оценки: From enrollment to the end of treatment period at 3 days]
  • Protocol Adherence [Срок оценки: From enrollment to the end of treatment period at 3 days]

Критерии участия

Критерии включения

  • Adult patients (≥18 years)
  • Within 12 hours of meeting septic shock diagnosis based on following Sepsis-3 criteria: requirement for vasopressors to maintain organ perfusion, lactate > 2 mmol/L, and suspected or confirmed infection)
  • Within 48 hours of intensive care unit admission.

Критерии исключения

  • Already receiving renal replacement therapy
  • Patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment
  • Patients who have limitations on medical therapy or restrictions on goals of care
  • Active bleeding causing hemodynamic instability
  • Veno-venous or veno-arterial extracorporeal membrane oxygenation
  • Previously enrolment in study
  • 10% or more of body surface area acute burn injury
  • Suspected or confirmed liver cirrhosis
  • Established allergy to sulfa drugs;
  • Patients receiving treatments that require continuous IV fluid infusions (e.g., diabetic ketoacidosis, diabetes insipidus)
  • Unable to measure fluid balance accurately
  • Contra-indication to study recommended interventions (e.g., diuretics, inotropes)
  • Unable to perform VEXUS due to anatomical barriers (e.g., surgical dressings);
  • Unable to complete VEXUS scan during the 6-hour resuscitation window
  • Moderate to Severe Tricuspid Regurgitation
  • Untreated Metabolic/biochemical findings (Hypokalemia \[K+\]< 3.0 mmol/L; metabolic alkalosis \[Bicarbonate > 40 mmol/L and/or pH > 7.55\], Hypomagnesemia \[Mg2+\] < 0.6, and Hypernatremia \[Na+\] > 155 mmol/L)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • London Health Sciences Center — London

Идентификаторы

NCT: NCT06696391 · 125708

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗