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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Metabolic resuscitation agent

Intervention Type 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).

hydrocortisone

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

Group Type PLACEBO_COMPARATOR

Hydrocortisone

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Hydrocortisone

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

Intervention Type DRUG

Other Intervention Names

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Hydrocortisone, vitamin C and vitamin B1

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No