Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

NCT ID: NCT05818826

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2025-05-31

Brief 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.

Detailed Description

According to secondary outcomes of several studies analyzed in systemic review was shown adverse events from corticosteroid uses including hyperglycemia, hypernatremia, muscle weakness, and superimposed infection. This trials will compare composite adverse events in early versus conventional cessation of hydrocortisone in septic shock.

Conditions

Septic Shock; Adverse Event; Hydrocortisone; Hyperglycemia; Hypernatremia; Muscle Weakness; Superimposed Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

early cessation group

The pharmacist uses 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. The experimental starts after required dose of vasopressor less than 0.1 mcg/kg/min. The nurse serially records capillary blood glucose and serum sodium following the doctor's order.

Group Type: EXPERIMENTAL

normal saline solution

Intervention Type: DRUG

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.

conventional cessation group

The pharmacist prepared hydrocortisone and 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. The nurse serially records capillary blood glucose and serum sodium following the doctor's order.

Group Type: PLACEBO_COMPARATOR

Hydrocortisone and normal saline solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

early cessation group; conventional cessation group

Eligibility Criteria

Inclusion Criteria

• Patient >= 18 years old
• Diagnosis Septic shock from the definition of SEPSIS III criteria in intensive care unit or medicine ward or surgical ward at Siriraj hospital
• Received at least 1 catecholamines and hydrocortisone at least 200 mg/d
• Maintain mean arterial pressure >= 65 mmHg even if titrate down catecholamines until low dose (<=0.1 mcg/kg/min)

Exclusion Criteria

• Patient sign Do not resuscitation and terminally ill
• Pregnancy
• Need long term steroid use due to other medical condition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Surat Tongyoo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Surat Tongyoo, Doctor

Role: CONTACT

surat.ton@mahidol.ac.th

+24197764

Kolanya Kangwanyotsak, Doctor

Role: CONTACT

tkolanya@hotmail.com

+24197764

Facility Contacts

Surat Tongyoo, MD

Role: primary

surat.ton@mahidol.ac.th

+6624197764

Kolanya Kangwanyotsak, MD

Role: backup

tkolanya@hotmail.com

+66875656234

Other Identifiers

SI 012/2023

Identifier Type: -

Identifier Source: org_study_id