Effects of Intravenous Metabolic Recovery Agent in Elderly Septic Patients on Prognosis and Microcirculation.

Официальное название

Clinical Study of the Effect of Intravenous Hydrocortisone Combined With Vitamin C and Vitamin B1 Infusion on Prognosis and Sublingual Microcirculation in Elderly Patients With Sepsis or Septic Shock.

Обзор

This study intends to observe the effect of intravenous hydrocortisone combined with vitamin C and vitamin B1 infusion on the prognosis and sublingual microcirculation in patients with sepsis or septic shock through a prospective randomized controlled study method.

Подробное описание

Shock is a common pathophysiological state in critical care medicine and occupies an important position. In recent years, some studies have had uesd metabolic resuscitation agent -- namely hydrocortisone + vitamin C + vitamin B1 cocktail therapy in the treatment of sepsis patients, studies found that this method may reduce the lactate level, improve renal failure and circulatory failure, and then improve the prognosis of such patients. There are also study groups that do not significantly prolong the survival of septic shock, suggesting that we need to screen out the use of metabolic resuscitation agents. Given the important role of vitamins in shock, uncontrolled inflammatory response, capillary leakage, and microcirculation dysfunction, whether the improved prognosis may be related to the patients' own vitamin levels. Vitamin deficiency is often present in the elderly.

This study aims to observe the effect of precision treatment of metabolic resuscitation agent on mortality and sublingual microcirculation in the follow-up prognosis of elderly septic patients on the basis of monitoring vitamin B1 and C levels in elderly septic patients.

Вмешательства

• Препарат Metabolic resuscitation agent
  Intervention group will receive intravenous hydrocortisone (200mg every 24 hours), vitamin C (1.5g every 6 hours), and thiamine (200 mg every 12 hours).
• Препарат Hydrocortisone
  Placebo group will receive intravenous hydrocortisone 200mg every 24 hours.

Первичные конечные точки

• 28-d Mortality [Срок оценки: 28 days after treatment]

Вторичные конечные точки (3)

• Perfused vessel density (PVD) [Срок оценки: 48 hours after treatment]
• proportion of perfusion vessels [Срок оценки: 48 hours after treatment]
• Lactate clearance, 48h, % [Срок оценки: 48 hours after treatment]

Критерии участия

Критерии включения

• Age ≥60 and ≤85 years old;
• Diagnosis of sepsis or septic shock;
• Clinical judgment for hydrocortisone treatment;
• Signing Informed Consent.

Критерии исключения

• patients in palliative care;
• uncontrolled malignancy with multiple metastases;
• ineffective surgical intervention for the infectious agent;
• estimated death within 24 hours;
• glucocorticoids used in the last 7 days;
• allergy to hydrocortisone, vitamin c or vitamin B1;
• inability to measure sublingual microcirculation.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongda Hospital Southeast University — Нанкин

Идентификаторы

NCT: NCT06723626 · 2023ZDSYLL355-P01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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