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NCT Number: NCT06723626

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

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Jingyuan Xu, M.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Hydrocortisone, vitamin C and vitamin B1

Hydrocortisone

Drug

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

Primary outcomes

  1. 28-d Mortality

    Time frame: 28 days after treatment

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

Secondary outcomes

  1. Perfused vessel density (PVD)

    Time frame: 48 hours after treatment

    Determinant of capillary diffusive capacity

  2. proportion of perfusion vessels

    Time frame: 48 hours after treatment

    sublingual microcirculation parameter

  3. Lactate clearance, 48h, %

    Time frame: 48 hours after treatment

    Tissue perfusion parameter

Study contacts

Contact information is provided by the study sponsor or research team.

Jingyuan Xu, M.D.

CONTACT

[email protected]

8602583262550

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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