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

Not Applicable

Recruiting

• Conditions: Septic Shock
• Interventions: Drug: Metabolic resuscitation agent; Drug: Hydrocortisone

• Registration Number: NCT06723626
• Lead Sponsor: Southeast University, China

Brief 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.

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 Timeline

• Study First Submitted: 2024-05-21
• Study Start: 2024-07-01
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metabolic resuscitation agents	Metabolic resuscitation agent	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).
hydrocortisone	Hydrocortisone	Patients in the control group received IV hydrocortisone (200mg every 24 hours).

Primary Outcome Measures

Name	Time	Method
28-d Mortality	28 days after treatment	patients with sepsis who died after treatment from any cause within 28 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China