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

Southeast University, China

Status: Enrolling

Conditions: Septic Shock

Treatments: Drug: Metabolic resuscitation agent; Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT06723626

2023ZDSYLL355-P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

metabolic resuscitation agents

Experimental group

Description:

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).

Treatment:

Drug: Metabolic resuscitation agent

hydrocortisone

Placebo Comparator group

Description:

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

Treatment:

Drug: Hydrocortisone