Comparing between hydrocortisone and combination of dexamethasone with fludrocortisone for increasing blood pressure in adult patients with low blood pressure due to severe infections: a double blinded non inferiority randomized controlled trial
Not Applicable
- Conditions
- Health Condition 1: A419- Sepsis, unspecified organism
- Registration Number
- CTRI/2024/08/072034
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
patients presenting with septic shock to ICU requiring vasopressors to maintain mean arterial pressure more than or equal to 65mmHg for at least 4 hours.
Exclusion Criteria
Patients already on steroids or likely to be on steroids for reasons other than septic shock.
Patient refusal
known allergies to study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time for shock reversal, defined as time from initiation of steroid therapy to discontinuation of noradrenaline for 24 hours to a target MAP of 65mmHg.Timepoint: at every 24 hours for 7 days.
- Secondary Outcome Measures
Name Time Method To compare between the two groups <br/ ><br>1) ICU mortality rate <br/ ><br>2)proportion of patients requiring reinitiation of norepinephrine <br/ ><br>3) mean daily insulin requirement during steroid therapy <br/ ><br>4)mean number of episodes of hyperglycemia during steroid therapy. <br/ ><br>5) proportion of new onset gastrointestinal bleed during steroid therapy <br/ ><br>6) proportion of patients requiring transfusion due to gastrointestinal bleed. <br/ ><br>7)proportion of patients showing new positive culture from a previously sterile site after initiating steroid therapy. <br/ ><br>Timepoint: at every 24 hours for 7 days.