Effects of Intravenous Metabolic Recovery Agent in Elderly Septic Patients on Prognosis and Microcirculation.
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metabolic resuscitation agent, Hydrocortisone.
- Who it may be relevant to
- Registry conditions: Septic Shock. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Drug 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). - Drug Hydrocortisone
Placebo group will receive intravenous hydrocortisone 200mg every 24 hours.
Primary outcome measures
- 28-d Mortality [Time frame: 28 days after treatment]
Secondary outcome measures (3)
- Perfused vessel density (PVD) [Time frame: 48 hours after treatment]
- proportion of perfusion vessels [Time frame: 48 hours after treatment]
- Lactate clearance, 48h, % [Time frame: 48 hours after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongda Hospital Southeast University — Nanjing
Identifiers
NCT: NCT06723626 · 2023ZDSYLL355-P01