Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock

NCT07383103 | Recruiting Phase 4

• 1 other identifier: 2025ky387
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

septic shock; hydrocortisone; fludrocortisone; mortality

Outcome Measures

Primary Outcomes (1)

• 90-day mortality

  All-cause mortality at day 90 after randomization

  90 days after randomization

Secondary Outcomes (3)

• 28-day mortality

  28 days after randomization

• ICU mortality

  From randomization to ICU discharge (up to 90 days)

• Hospital mortality

  From randomization to hospital discharge (up to 90 days)

Other Outcomes (10)

• Shock reversal time

  From randomization up to 28 days

• ICU length of stay

  From randomization to ICU discharge (up to 90 days)

• Hospital length of stay

  From randomization to hospital discharge (up to 90 days)

Study Arms (2)

Hydrocortisone plus Fludrocortisone

EXPERIMENTAL

Hydrocortisone: 200 mg per day administered by continuous intravenous infusion for up to 7 days or until ICU discharge, whichever occurs first. Fludrocortisone: 50 μg administered orally or via nasogastric tube once daily for up to 7 days or until ICU discharge, whichever occurs first.

Drug: Hydrocortisone plus Fludrocortisone

Standard care

ACTIVE COMPARATOR

Patients will receive standard care for septic shock according to current international guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures, including the use of hydrocortisone at the discretion of the treating physician, but without fludrocortisone.

Other: Standard care

Interventions

Hydrocortisone plus Fludrocortisone DRUG

Hydrocortisone will be administered at a dose of 200 mg per day by continuous intravenous infusion. Fludrocortisone will be administered at a dose of 50 μg once daily orally or via nasogastric tube. Both drugs will be given for up to 7 days or until ICU discharge, whichever occurs first.

Also known as: Hydrocortisone Injection, Fludrocortisone Acetate Tablets

Hydrocortisone plus Fludrocortisone

Standard care OTHER

Patients will receive standard care for septic shock according to current international and institutional guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures. Fludrocortisone will not be administered.Hydrocortisone may be administered at the discretion of the treating physician.

Standard care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1)18≤Age≤90; (2)Diagnosis of septic shock within 12 h.

You may not qualify if:

• Patients meeting any of the following conditions will be excluded:
• Systemic corticosteroid therapy within the last 3 months before septic shock;
• High-dose steroid therapy;
• Immunosuppression;
• Pregnant;
• Known allergy to hydrocortisone or fludrocortisone;
• Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting;
• Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
• Refusal of the attending staff or patient family;
• Current participation in another clinical trial.

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Hydrocortisone; Fludrocortisone; fludrocortisone acetate; Standard of Care

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Qingquan Lyu, Master

  Northern Jiangsu People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingquan Lyu, Master

CONTACT

0086-18051063899; bonhomie2014@163.com

Xiaohua Gu, Master

CONTACT

0086-18051062325; njguxiaohua@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 3, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)