Early Versus Conventional Cessation of Hydrocortisone in Septic Shock (CESSHYDRO)

April 4, 2024 updated by: Mahidol University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Other Names:
  • early cessation group
Placebo Comparator: 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.
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.
Other Names:
  • conventional cessation group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 14 days after randomization or until discharge from hospital, whichever came first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Concentration of insulin needed due to hyperglycemia
Time Frame: within 14 days after randomization or until discharge from hospital, whichever came first
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
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 < 80 mg/dL
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
Number of participants with capillary blood glucose ≥ 150 mg/dL
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
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
Time to need of fluid bolus
Time Frame: within 14 days after randomization or until discharge from hospital, whichever came first
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
Time to reversal of shock
Time Frame: within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first
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
Number of participants with New onset of infection within 28 days
Time Frame: 28 days
Number of participants with New onset of infection within 28 days
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 measured as days from randomization until discharge from ICU
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
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
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
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
Level of minimum and maximum mean arterial pressure
Time Frame: within 14 days after randomization or until discharge from hospital, whichever came first
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
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 who survive in 28 days with free mechanical ventilator
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 who survive in 28 days with free mechanical ventilator
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
Number of participants who survive in 28 days with free mechanical ventilator
28 days after randomization or until discharge from hospital, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Surat Tongyoo, Doctor, Mahidol university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SI 012/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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