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Comparison of hydrocortisone administration methods in patients with septic shock

Comparison of hydrocortisone administration methods (continuous intravenous infusion and intermittent intravenous bolus injection) on adrenal recovery in patients with septic shock admitted to the intensive care unit

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250730066694N1
Enrollment
24
Registered
2025-08-04
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

septic shock. Severe sepsis with septic shock

Interventions

Intervention 1: Intervention group: Continuous intravenous infusion group: Patients in this group are treated with 200 mg daily hydrocortisone (Dana Pharmaceutical Company, Tabriz, Iran), diluted in 5

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age=18 years Diagnosis of septic shock

Exclusion criteria

Exclusion criteria: Long-term use of glucocorticoids more than 5 mg of prednisolone daily (or equivalent) for more than one month prior to admission Receiving dexamethasone or corticosteroid injections at any dose within 24 hours before recruitment Known adrenal or pituitary disorders including Addison's disease, pituitary insufficiency, adrenal tumors Use of hypothalamic-pituitary-adrenal axis-disrupting drugs Sensitivity to hydrocortisone Systemic fungal infection Psychiatric disorders Expected survival time less than 24 hours Simultaneous participation in another clinical trial Pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Adrenal recovery. Timepoint: Immediately and 48 hours after hydrocortisone discontinuation. Method of measurement: Based on vital signs and hemodynamic parameters and electrolyte status extracted from the patient's records.

Secondary

MeasureTime frame
Cumulative dose of vasopressor. Timepoint: At the beginning of the study (before the start of the intervention) and then daily for up to 7 days. Method of measurement: Recording the vasopressor dose in the patient's record.;Duration of vasopressor administration. Timepoint: At the beginning of the study (before the start of the intervention) and then daily for up to 7 days. Method of measurement: Recording the time of initiation and discontinuation of the vasopressor in the patient's record.;The time at which the second vasopressor should be added. Timepoint: At the beginning of the study (before the start of the intervention) and then daily for up to 7 days. Method of measurement: Patient follow-up and recording the time of initiation of the vasopressor in the patient's record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParinaz Sadat Mahmoudi

Tehran University of Medical Sciences

p-mahmoudi@razi.tums.ac.ir+98 21 6612 9502

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026