Septic ShockPhase 2CESSHYDRONCT05818826
Early Versus Conventional Cessation of Hydrocortisone in Septic Shock
A Phase 2 study testing normal saline solution and Hydrocortisone and normal saline solution in people with Septic Shock and Adverse Event, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Adverse Event, Hydrocortisone
- What is being tested?
- normal saline solution and Hydrocortisone and normal saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- 5 Jul 2023to May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patient sign Do not resuscitation and terminally ill
- Pregnancy
- Need long term steroid use due to other medical condition
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Surat Tongyoo, MD, +6624197764, surat.ton@mahidol.ac.th
Kolanya Kangwanyotsak, MD, +66875656234, tkolanya@hotmail.com
About this study
Official title: Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
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.
Read the 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
- Being tested
- normal saline solution, Hydrocortisone and normal saline solution
- Keywords
- septic shock, composite adverse events, hydrocortisone, hyperglycemia, hypernatremia, muscle weakness, superimposed infection
- Medical subject headings
- Shock, Septic, Hyperglycemia, Hypernatremia, Muscle Weakness, Superinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal saline solutionDrug
Also called early cessation group
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 solutionDrug
Also called conventional cessation group
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.
| Study group | Role | What they receive |
|---|---|---|
| early cessation group | Experimental | 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. Receives: Drug: normal saline solution |
| conventional cessation group | Placebo comparator | 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. Receives: Drug: Hydrocortisone and normal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 14 days after randomization or until discharge from hospital, whichever came first
Secondary outcomes (15)
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
Measured: 28-day mortality from any cause start until 28 day after randomization or until discharge from hospital, whichever came first
Concentration of insulin needed due to hyperglycemia
Total insulin used to lower capillary blood sugar if level of glucose more than 180 mg/dL
Measured: within 14 days after randomization or until discharge from hospital, whichever came first
Number of participants with hypoglycemia
Number of participants with capillary blood glucose < 80 mg/dL
Measured: within 14 days after randomization or until discharge from hospital, whichever came first
Number of participants with capillary blood glucose ≥ 150 mg/dL
Number of participants with capillary blood glucose ≥ 150 mg/dL
Measured: within 14 days after randomization or until discharge from hospital, whichever came first
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
Measured: within 14 days after randomization or until discharge from hospital, whichever came first
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
Measured: within 14 days after randomization or until discharge from hospital, whichever came first
Time to reversal of shock
Duration measured as hours from randomization until off vasopressor
Measured: within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first
Number of participants with New onset of infection within 28 days
Number of participants with New onset of infection within 28 days
Measured: 28 days
Duration of ICU length of stay
Duration measured as days from randomization until discharge from ICU
Measured: 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
Duration of Ventilator free day
Duration measured as hours from off ventilator until on ventilator or reintubation
Measured: 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
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
Measured: 7 days after randomization or until discharge from hospital, whichever came first
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
Measured: within 14 days after randomization or until discharge from hospital, whichever came first
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
Measured: 28 days after randomization or until discharge from hospital, whichever came first
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
Measured: 28 days after randomization or until discharge from hospital, whichever came first
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
Measured: 28 days after randomization or until discharge from hospital, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start5 Jul 2023
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surat Tongyoo, Doctor, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818826
- Sponsor's protocol ID
- SI 012/2023
- Acronym
- CESSHYDRO
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous identification data will be prepared per request, after study publication 6 months
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05818826
- Acronym / sponsor ID
- CESSHYDRO / SI 012/2023
- Conditions
- Septic Shock, Adverse Event, Hydrocortisone, Hyperglycemia, Hypernatremia, Muscle Weakness
- Keywords
- septic shock, composite adverse events, hydrocortisone, hyperglycemia, hypernatremia, muscle weakness, superimposed infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| early cessation group | Experimental | Drug: normal saline solutionThe 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. |
| conventional cessation group | Placebo comparator | Drug: Hydrocortisone and normal saline solutionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Patient sign Do not resuscitation and terminally ill
- Pregnancy
- Need long term steroid use due to other medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal saline solutionAlso: early cessation groupPrepare 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 | early cessation group |
| Hydrocortisone and normal saline solutionAlso: conventional cessation groupPrepare 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. | Drug | conventional cessation group |
Primary outcome
Composite adverse events of early versus conventional cessation of hydrocortisone
Time frame: within 14 days after randomization or until discharge from hospital, whichever came first
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
15 secondary outcomes
Number of participants with 28-day mortality from any cause 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
Concentration of insulin needed due to hyperglycemia
Time frame: within 14 days after randomization or until discharge from hospital, whichever came first
Number of participants with hypoglycemia
Time frame: within 14 days after randomization or until discharge from hospital, whichever came first
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
Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge
Time frame: within 14 days after randomization or until discharge from hospital, whichever came first
Time to need of fluid bolus
Time frame: within 14 days after randomization or until discharge from hospital, whichever came first
Time to reversal of shock
Time frame: within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first
Number of participants with New onset of infection within 28 days
Time frame: 28 days
Duration of ICU length of stay
Time frame: 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
Duration of Ventilator free day
Time frame: 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone
Time frame: 7 days after randomization or until discharge from hospital, whichever came first
Level of minimum and maximum mean arterial pressure
Time frame: within 14 days after randomization or until discharge from hospital, whichever came first
Number of participants with Alive days in 28 days with free mechanical ventilator
Time frame: 28 days after randomization or until discharge from hospital, whichever came first
Number of participants with Alive days in 28 days with free renal replacement therapy
Time frame: 28 days after randomization or until discharge from hospital, whichever came first
Number of participants with Alive days in 28 days with free organ supports
Time frame: 28 days after randomization or until discharge from hospital, whichever came first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: Yes. Anonymous identification data will be prepared per request, after study publication 6 months
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surat Tongyoo, Doctor principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing normal saline solution and Hydrocortisone and normal saline solution in people with Septic Shock and Adverse Event, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surat Tongyoo, Doctor (+24197764, surat.ton@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite adverse events of early versus conventional cessation of hydrocortisone (time frame: within 14 days after randomization or until discharge from hospital, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.