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Effect of improvement in blood pressure as a response to hydrocortisone administration on mortality of patients presenting with septic shock

PROGNOSTIC VALUE OF HAEMODYNAMIC RESPONSE TO HYDROCORTISONE IN PATIENTS PRESENTING WITH SEPTIC SHOCK

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029672
Enrollment
213
Registered
2020-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R578- Other shock Health Condition 2: R652- Severe sepsis

Interventions

Intervention1: Nil: Nil

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. On mechanical ventilation 2. Septic shock of less than 24 hrs

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to steroids 2. Pregnancy and lactation. 3. More than one vasopressor requirement. 4. Immunodeficiency 5. Malignancy 6. Patients on drugs affecting HPA (eg: Etomidate , Ketoconazole) 7. If hydrocortisone is indicated for purpose other than septic shock 8. Death is inevitable or imminent during this admission and the patient relative is not willing for active treatment. 9. High risk of bleeding 10. Short term steroid in past 1 month/long term steroid in past 6 month 11. Patients with known adrenal insufficiency 12. Shock possibly attributed to other non- sepsis related causes

Design outcomes

Primary

MeasureTime frame
To compare mortality among patients showing hemodynamic response to hydrocortisone (responders) versus non- respondersTimepoint: At 30 days from enrollment in the study—

Secondary

MeasureTime frame
1. To compare the baseline variables among patients presenting with septic shock who show haemodynamic response to hydrocortisone (responders) versus non responders.Timepoint: From inclusion in study to 1st 24 hours of enrollment;To compare mortality among patients showing haemodynamic response to hydrocortisone (responders) within 24 hrs after initiation versus non responders.Timepoint: At 90 days from enrollment in the study;To compare outcome variables (ie. No. of patient with recurrence of shock, recurrence of MV, number of patients requiring RRT, number of patients with new onset bacteraemia or fungaemia, number of patients requiring transfusion during ICU stay, time to resolution of shock, time to cessation of initial MV, time to discharge from ICU and hospital, Organ failure free days/MV free days/vasopressor free days, number of days alive and outside hospital) among responders versus non responders.Timepoint: From inclusion in study to 30 day of enrollment—

Countries

India

Contacts

Public ContactDr Gaurav Jain

Aiims Rishikesh

gauravhld@gmail.com8808631209

Outcome results

None listed

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