Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

Septic Shock Clinical Trial

— CESSHYDRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818826
• Other study ID #: SI 012/2023
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Mahidol University
• Contact: Surat Tongyoo, Doctor
• Phone: +24197764
• Email: surat.ton[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event
• Hydrocortisone
• Hyperglycemia
• Hypernatremia
• Muscle Weakness
• Paresis
• Septic Shock
• Shock
• Shock, Septic

Intervention

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.
• 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

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite adverse events of early versus conventional cessation of hydrocortisone	including level of capillary blood glucose >= 180mg/dL(Hyperglycemia) , Plasma level of sodium>= 150mmol/L(Hypernatremia), new onset of infection , and neuromuscular weakness(muscular impairment rating scale>1	within 14 days after randomization or until discharge from hospital, whichever came first
Secondary	Number of participants with 28-day mortality from any cause or until discharge from hospital	death from any cause until 28-day after randomization or until discharge from hospital	28-day mortality from any cause start until 28 day after randomization or until discharge from hospital, whichever came first
Secondary	Concentration of insulin needed due to hyperglycemia	Total insulin used to lower capillary blood sugar if level of glucose more than 180 mg/dL	within 14 days after randomization or until discharge from hospital, whichever came first
Secondary	Number of participants with hypoglycemia	Number of participants with capillary blood glucose < 80 mg/dL	within 14 days after randomization or until discharge from hospital, whichever came first
Secondary	Number of participants with capillary blood glucose = 150 mg/dL	Number of participants with capillary blood glucose = 150 mg/dL	within 14 days after randomization or until discharge from hospital, whichever came first
Secondary	Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge	Duration measured as hours from off vasopressor until re-initiation at least 0.05 mcg/kg/min until 14 day after randomization or until hospital discharge	within 14 days after randomization or until discharge from hospital, whichever came first
Secondary	Time to need of fluid bolus	Duration measured as hours from randomization until fluid bolus at least 250 ml in 10-15 minutes until 14 day after randomization or until hospital discharge	within 14 days after randomization or until discharge from hospital, whichever came first
Secondary	Time to reversal of shock	Duration measured as hours from randomization until off vasopressor	within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first
Secondary	Number of participants with New onset of infection within 28 days	Number of participants with New onset of infection within 28 days	28 days
Secondary	Duration of ICU length of stay	Duration measured as days from randomization until discharge from ICU	14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
Secondary	Duration of Ventilator free day	Duration measured as hours from off ventilator until on ventilator or reintubation	14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
Secondary	Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone	Number of participants with Lung injury score at day1, day3, day7 after first dose hydrocortisone	7 days after randomization or until discharge from hospital, whichever came first
Secondary	Level of minimum and maximum mean arterial pressure	Level of minimum and maximum mean arterial pressure until 14 days after randomization or until hospital discharge	within 14 days after randomization or until discharge from hospital, whichever came first
Secondary	Number of participants with Alive days in 28 days with free mechanical ventilator	Number of participants who survive in 28 days with free mechanical ventilator	28 days after randomization or until discharge from hospital, whichever came first
Secondary	Number of participants with Alive days in 28 days with free renal replacement therapy	Number of participants who survive in 28 days with free mechanical ventilator	28 days after randomization or until discharge from hospital, whichever came first
Secondary	Number of participants with Alive days in 28 days with free organ supports	Number of participants who survive in 28 days with free mechanical ventilator	28 days after randomization or until discharge from hospital, whichever came first