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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Metabolic resuscitation agent; Drug: Hydrocortisone

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyuan Xu, M.D.; Phone Number: 8602583262550; Email: xujingyuanmail@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
      • Contact: Jingyuan Xu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metabolic resuscitation agents; Patients in the intervention group received IV hydrocortisone (200mg every 24 hours), vitamin C (1.5g every 6 hours), and thiamine (200 mg every 12 hours).	Drug: 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).; Other Names: Hydrocortisone, vitamin C and vitamin B1
Placebo Comparator: hydrocortisone; Patients in the control group received IV hydrocortisone (200mg every 24 hours).	Drug: Hydrocortisone; Placebo group will receive intravenous hydrocortisone 200mg every 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-d Mortality	patients with sepsis who died after treatment from any cause within 28 days	28 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfused vessel density (PVD)	Determinant of capillary diffusive capacity	48 hours after treatment
proportion of perfusion vessels	sublingual microcirculation parameter	48 hours after treatment
Lactate clearance, 48h, %	Tissue perfusion parameter	48 hours after treatment

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Jingyuan Xu, M.D., Zhongda hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: septic shock; microcirculation; sepsis; mortality; hydrocortisone; vitamin C; vitamin B1
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Shock, Septic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Micronutrients; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Vitamins
• Other Study ID Numbers: 2023ZDSYLL355-P01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No