NCT07383103 Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock
| NCT ID | NCT07383103 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northern Jiangsu People's Hospital |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 336 participants in total. It began in 2026-03-02 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the combination therapy of hydrocortisone and fludrocortisone among adult patients with septic shock.
Eligibility Criteria
Inclusion Criteria: (1)18≤Age≤90; (2)Diagnosis of septic shock within 12 h. Exclusion Criteria: Patients meeting any of the following conditions will be excluded: 1. Systemic corticosteroid therapy within the last 3 months before septic shock; 2. High-dose steroid therapy; 3. Immunosuppression; 4. Pregnant; 5. Known allergy to hydrocortisone or fludrocortisone; 6. Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting; 7. Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician); 8. Refusal of the attending staff or patient family; 9. Current participation in another clinical trial.
Contact & Investigator
Qingquan Lyu, Master
PRINCIPAL INVESTIGATOR
Northern Jiangsu People's Hospital
Frequently Asked Questions
Who can join the NCT07383103 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07383103 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07383103 currently recruiting?
Yes, NCT07383103 is actively recruiting participants. Contact the research team at bonhomie2014@163.com for enrollment information.
Where is the NCT07383103 trial being conducted?
This trial is being conducted at Yangzhou, China.
Who is sponsoring the NCT07383103 clinical trial?
NCT07383103 is sponsored by Northern Jiangsu People's Hospital. The principal investigator is Qingquan Lyu, Master at Northern Jiangsu People's Hospital. The trial plans to enroll 336 participants.