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

NCT06723626 | Recruiting

• 1 other identifier: 2023ZDSYLL355-P01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

hydrocortisone; vitamin C; vitamin B1; sepsis; septic shock; mortality; microcirculation

Outcome Measures

Primary Outcomes (1)

• 28-d Mortality

  patients with sepsis who died after treatment from any cause within 28 days

  28 days after treatment

Secondary Outcomes (3)

• Perfused vessel density (PVD)

  48 hours after treatment

• proportion of perfusion vessels

  48 hours after treatment

• Lactate clearance, 48h, %

  48 hours after treatment

Study Arms (2)

metabolic resuscitation agents

EXPERIMENTAL

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

hydrocortisone

PLACEBO COMPARATOR

Patients in the control group received IV hydrocortisone (200mg every 24 hours).

Drug: Hydrocortisone

Interventions

Metabolic resuscitation agent DRUG

Intervention group will receive intravenous hydrocortisone (200mg every 24 hours), vitamin C (1.5g every 6 hours), and thiamine (200 mg every 12 hours).

Also known as: Hydrocortisone, vitamin C and vitamin B1

metabolic resuscitation agents

Hydrocortisone DRUG

Placebo group will receive intravenous hydrocortisone 200mg every 24 hours.

hydrocortisone

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Hydrocortisone; Ascorbic Acid; Thiamine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Jingyuan Xu, M.D.

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Xu, M.D.

CONTACT

8602583262550; xujingyuanmail@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: December 9, 2024
• Study Start: July 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CN (1)