Effect of improvement in blood pressure as a response to hydrocortisone administration on mortality of patients presenting with septic shock
Not Applicable
- Conditions
- Health Condition 1: R578- Other shockHealth Condition 2: R652- Severe sepsis
- Registration Number
- CTRI/2020/12/029672
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.On mechanical ventilation
2. Septic shock of less than 24 hrs
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare mortality among patients showing hemodynamic response to hydrocortisone (responders) versus non- respondersTimepoint: At 30 days from enrollment in the study
- Secondary Outcome Measures
Name Time Method 1. To compare the baseline variables among patients presenting with <br/ ><br>septic shock who show haemodynamic response to hydrocortisone <br/ ><br>(responders) versus non responders.Timepoint: From inclusion in study to 1st 24 hours of enrollment;To compare mortality among patients showing haemodynamic response to <br/ ><br>hydrocortisone (responders) within 24 hrs after initiation versus non <br/ ><br>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