NCT05136560

Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis

A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: CHA University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of early administration of two different doses of dexamethasone in high risk septic patients.

Detailed description

The septic adult patients of high risk would be enrolled in 2 emergency departments. Sepsis would be defined by Sepsis-3 definition. High risk is defined as initial systolic blood pressure less than 90 mmHg or blood lactate level over 2 mmol/L. The enrolled patients would be randomized to 3 groups: control, low dose dexamethasone (0.1 mg/kg iv), and high dose dexamethasone (0.2mg/kg iv). The study drug is blinded and administered after enrollment for 2 days. Sample size would be 102, considering 10% of drop-out rate, allocating 30 patients to each groups. Efficacy would be evaluated as follows; 28 day and 90 day mortality, time to septic shock, time to shock reversal, administration of steroid according to guideline, ventilator free days, Continuous renal replacement, Length of stay in ICU or hospital, delta SOFA score on day 3 and day 7, Safety would be evaluated as follows; Superinfection Gastrointestinal bleeding, Hyperglycemia, Hypernatremia

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	Dexamethasone	Intervention drugs would be administered for 1 or 2 days.

Timeline

• Start date: 2021-01-15
• Primary completion: 2025-12-30
• Completion: 2026-02-28
• First posted: 2021-11-29
• Last updated: 2025-05-31

Locations

2 sites across 1 country: South Korea