Clinical trial NCT06723626: Effects of Intravenous Metabolic Recovery Agent in Elderly Septic Patients on Prognosis and Microcirculation.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Septic Shock
Keywords: hydrocortisone
vitamin C
vitamin B1
sepsis
septic shock
mortality
microcirculation
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: 28-d Mortality
timeFrame: 28 days after treatment
Secondary outcomes:
measure: Perfused vessel density (PVD)
timeFrame: 48 hours after treatment
measure: proportion of perfusion vessels
timeFrame: 48 hours after treatment
measure: Lactate clearance, 48h, %
timeFrame: 48 hours after treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Jingyuan Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: