Back to resultsEarly Versus Conventional Cessation of Hydrocortisone in Septic Shock (CESSHYDRO)
Primary Purpose
Septic Shock, Adverse Event, Hydrocortisone
Status
Recruiting
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
normal saline solution
Hydrocortisone and normal saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring septic shock, composite adverse events, hydrocortisone, hyperglycemia, hypernatremia, muscle weakness, superimposed infection
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
Sites / Locations
- Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
early cessation group
conventional cessation group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Concentration of insulin needed due to hyperglycemia
Total insulin used to lower capillary blood sugar if level of glucose more than 180 mg/dL
Number of participants with hypoglycemia
Number of participants with capillary blood glucose < 80 mg/dL
Number of participants with capillary blood glucose ≥ 150 mg/dL
Number of participants with capillary blood glucose ≥ 150 mg/dL
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
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
Time to reversal of shock
Duration measured as hours from randomization until off vasopressor
Number of participants with New onset of infection within 28 days
Number of participants with New onset of infection within 28 days
Duration of ICU length of stay
Duration measured as days from randomization until discharge from ICU
Duration of Ventilator free day
Duration measured as hours from off ventilator until on ventilator or reintubation
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05818826
Brief Title
Early Versus Conventional Cessation of Hydrocortisone in Septic Shock
Acronym
CESSHYDRO
Official Title
Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Adverse Event, Hydrocortisone, Hyperglycemia, Hypernatremia, Muscle Weakness, Superimposed Infection
Keywords
septic shock, composite adverse events, hydrocortisone, hyperglycemia, hypernatremia, muscle weakness, superimposed infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Pharmacist who does not involve in patient enrollment nor treatment will prepared hydrocortisone or placebo in the identical container, before the study drug will be discontinued from patients , according to their treatment arm.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
early cessation group
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional cessation group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline solution
Other Intervention Name(s)
early cessation group
Intervention Description
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
Intervention Name(s)
Hydrocortisone and normal saline solution
Other Intervention Name(s)
conventional cessation group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite adverse events of early versus conventional cessation of hydrocortisone
Description
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
Time Frame
within 14 days after randomization or until discharge from hospital, whichever came first
Secondary Outcome Measure Information:
Title
Number of participants with 28-day mortality from any cause or until discharge from hospital
Description
death from any cause until 28-day after randomization or until discharge from hospital
Time Frame
28-day mortality from any cause start until 28 day after randomization or until discharge from hospital, whichever came first
Title
Concentration of insulin needed due to hyperglycemia
Description
Total insulin used to lower capillary blood sugar if level of glucose more than 180 mg/dL
Time Frame
within 14 days after randomization or until discharge from hospital, whichever came first
Title
Number of participants with hypoglycemia
Description
Number of participants with capillary blood glucose < 80 mg/dL
Time Frame
within 14 days after randomization or until discharge from hospital, whichever came first
Title
Number of participants with capillary blood glucose ≥ 150 mg/dL
Description
Number of participants with capillary blood glucose ≥ 150 mg/dL
Time Frame
within 14 days after randomization or until discharge from hospital, whichever came first
Title
Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge
Description
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
Time Frame
within 14 days after randomization or until discharge from hospital, whichever came first
Title
Time to need of fluid bolus
Description
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
Time Frame
within 14 days after randomization or until discharge from hospital, whichever came first
Title
Time to reversal of shock
Description
Duration measured as hours from randomization until off vasopressor
Time Frame
within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first
Title
Number of participants with New onset of infection within 28 days
Description
Number of participants with New onset of infection within 28 days
Time Frame
28 days
Title
Duration of ICU length of stay
Description
Duration measured as days from randomization until discharge from ICU
Time Frame
14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
Title
Duration of Ventilator free day
Description
Duration measured as hours from off ventilator until on ventilator or reintubation
Time Frame
14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
Title
Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone
Description
Number of participants with Lung injury score at day1, day3, day7 after first dose hydrocortisone
Time Frame
7 days after randomization or until discharge from hospital, whichever came first
Title
Level of minimum and maximum mean arterial pressure
Description
Level of minimum and maximum mean arterial pressure until 14 days after randomization or until hospital discharge
Time Frame
within 14 days after randomization or until discharge from hospital, whichever came first
Title
Number of participants with Alive days in 28 days with free mechanical ventilator
Description
Number of participants who survive in 28 days with free mechanical ventilator
Time Frame
28 days after randomization or until discharge from hospital, whichever came first
Title
Number of participants with Alive days in 28 days with free renal replacement therapy
Description
Number of participants who survive in 28 days with free mechanical ventilator
Time Frame
28 days after randomization or until discharge from hospital, whichever came first
Title
Number of participants with Alive days in 28 days with free organ supports
Description
Number of participants who survive in 28 days with free mechanical ventilator
Time Frame
28 days after randomization or until discharge from hospital, whichever came first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surat Tongyoo, Doctor
Phone
+24197764
Email
surat.ton@mahidol.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Kolanya Kangwanyotsak, Doctor
Phone
+24197764
Email
tkolanya@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, Doctor
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, MD
Phone
+6624197764
Email
surat.ton@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Kolanya Kangwanyotsak, MD
Phone
+66875656234
Email
tkolanya@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymous identification data will be prepared per request, after study publication 6 months
IPD Sharing Time Frame
6 months post study publication
IPD Sharing Access Criteria
Request to principal investigation, after protocol approval from ethical committee
Learn more about this trial
Early Versus Conventional Cessation of Hydrocortisone in Septic Shock
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