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Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

NCT05818826 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-04-05

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Surat Tongyoo, Doctor · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2025-04-30
Completion
2025-05-31

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818826 on ClinicalTrials.gov