Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

NCT05818826 | Recruiting Phase 2

• 1 other identifier: SI 012/2023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Adverse Event; Hydrocortisone; Hyperglycemia; Hypernatremia; Muscle Weakness; Superimposed Infection

Keywords

septic shock; composite adverse events; hydrocortisone; hyperglycemia; hypernatremia; muscle weakness; superimposed infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

• Concentration of insulin needed due to hyperglycemia

  within 14 days after randomization or until discharge from hospital, whichever came first

• 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 ≥ 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

  within 14 days after randomization or until discharge from hospital, whichever came first

Study Arms (2)

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.

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.

Drug: Hydrocortisone and normal saline solution

Interventions

normal saline solution DRUG

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.

Also known as: early cessation group

early cessation group

Hydrocortisone and normal saline solution DRUG

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.

Also known as: conventional cessation group

conventional cessation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient sign Do not resuscitation and terminally ill
• Pregnancy
• Need long term steroid use due to other medical condition

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Hyperglycemia; Hypernatremia; Muscle Weakness; Superinfection

Interventions

Saline Solution; Hydrocortisone

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Opportunistic Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Surat Tongyoo, Doctor

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surat Tongyoo, Doctor

CONTACT

+24197764; surat.ton@mahidol.ac.th

Kolanya Kangwanyotsak, Doctor

CONTACT

+24197764; tkolanya@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 19, 2023
• Study Start: July 5, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 6 months post study publication
• Access Criteria: Request to principal investigation, after protocol approval from ethical committee

Locations

TH (1)