Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05818826
Collaborator
(none)
180
1
2
24
7.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: normal saline solution
  • Drug: Hydrocortisone and normal saline solution
Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Composite adverse events of early versus conventional cessation of hydrocortisone [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

    Secondary Outcome Measures

    1. Number of participants with 28-day mortality from any cause 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]

      death from any cause until 28-day after randomization or until discharge from hospital

    2. Concentration of insulin needed due to hyperglycemia [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

    3. Number of participants with hypoglycemia [within 14 days after randomization or until discharge from hospital, whichever came first]

      Number of participants with capillary blood glucose < 80 mg/dL

    4. Number of participants with capillary blood glucose ≥ 150 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

    5. Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge [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

    6. Time to need of fluid bolus [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

    7. Time to reversal of shock [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

    8. Number of participants with New onset of infection within 28 days [28 days]

      Number of participants with New onset of infection within 28 days

    9. Duration of ICU length of stay [14 days after first dose hydrocortisone or until discharge from hospital, whichever came first]

      Duration measured as days from randomization until discharge from ICU

    10. Duration of Ventilator free day [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

    11. Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone [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

    12. Level of minimum and maximum mean arterial pressure [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

    13. Number of participants with Alive days in 28 days with free mechanical ventilator [28 days after randomization or until discharge from hospital, whichever came first]

      Number of participants who survive in 28 days with free mechanical ventilator

    14. Number of participants with Alive days in 28 days with free renal replacement therapy [28 days after randomization or until discharge from hospital, whichever came first]

      Number of participants who survive in 28 days with free mechanical ventilator

    15. Number of participants with Alive days in 28 days with free organ supports [28 days after randomization or until discharge from hospital, whichever came first]

      Number of participants who survive in 28 days with free mechanical ventilator

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Surat Tongyoo, Doctor, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT05818826
    Other Study ID Numbers:
    • SI 012/2023
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 19, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Mahidol University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2023