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RECRUITING
NCT05818826
PHASE2

Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

Sponsor: Mahidol University

View on ClinicalTrials.gov

Summary

Septic shock is one of the causes of death in ICU and hospital. Refractory shock is the problem which healthcare providers should recognize though it is difficult to handle with. The corticosteroid called hydrocortisone is one of the treatment in refractory septic shock which requires vasopressor to maintain blood pressure. In recovery phase of septic shock and weaning off vasopressor, there is no definite way to taper off hydrocortisone.

Official title: Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2023-07-05

Completion Date

2025-05

Last Updated

2024-04-05

Healthy Volunteers

No

Interventions

DRUG

normal saline solution

Prepare 100 ml of normal saline solution, packed out in the same format, dose, and administration of the drug were exactly the same as in the conventional cessation group.

DRUG

Hydrocortisone and normal saline solution

Prepare hydrocortisone with normal saline solution 100 ml starts dose at least 200 mg/day according to doctor's order after patient meets the criteria of refractory septic shock then continues conventional cessation of hydrocortisone according to doctor's order after required dose of vasopressor less than 0.1 mcg/kg/min.

Locations (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand