Effects of a vitamin and hydrocortisone treatment on elderly patients with septic shock
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.
This study tests if a combination of hydrocortisone and vitamins can help older patients with septic shock feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Southeast University, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06723626 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of an intravenous combination of hydrocortisone, vitamin C, and vitamin B1 on the prognosis and microcirculation of elderly patients suffering from sepsis or septic shock. Utilizing a prospective randomized controlled design, the study aims to determine whether this metabolic resuscitation therapy can improve patient outcomes by monitoring vitamin levels and their correlation with prognosis. The research focuses on the potential benefits of this treatment in reducing lactate levels and improving renal and circulatory function in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly individuals aged 60 to 85 who have been diagnosed with sepsis or septic shock.
Not a fit: Patients in palliative care or those with uncontrolled malignancies or severe allergies to the treatment components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and recovery outcomes for elderly patients with septic shock.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of metabolic resuscitation agents in sepsis treatment, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Jingyuan Xu, M.D. — Zhongda Hospital
- Study coordinator: Jingyuan Xu, M.D.
- Email: xujingyuanmail@163.com
- Phone: 8602583262550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.