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

Last updated: March 11, 2025
Sponsor: Southeast University, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

Placebo

Hydrocortisone

Metabolic resuscitation agent

Clinical Study ID

NCT06723626
2023ZDSYLL355-P01
  • Ages 60-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥60 and ≤85 years old;

  • Diagnosis of sepsis or septic shock;

  • Clinical judgment for hydrocortisone treatment;

  • Signing Informed Consent.

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Placebo
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
November 30, 2025

Study Description

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.

Connect with a study center

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

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