Early Adrenaline versus placebo in children with low blood pressure due to sepsis: A Placebo Controlled Blinded Randomised Clinical Trial
Not Applicable
- Conditions
- Health Condition 1: I958- Other hypotension
- Registration Number
- CTRI/2020/05/025078
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children aged 12 years or younger admitted with hypotensive septic shock
Exclusion Criteria
1.Patients referred on vasoactive drug infusion
2.Pre-existing heart disease or renal failure
3.Severe acute malnutrition and known immunocompromised state
4.Dengue shock syndrome
5.Inability to obtain a 2nd vascular access in time
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resolution of shock at 1 hour of resuscitation, defined as achievement of therapeutic end points of resuscitation(Heart rate, systolic blood pressure greater than fifth percentile for age, capillary refill time less than or equal to 2 seconds and level of consciousness).Timepoint: 1 hour
- Secondary Outcome Measures
Name Time Method ength of PICU stay and 28 day all-cause mortalityTimepoint: 28 days;Proportion of children with resolution of shock at any point in time and the total duration for resolutionTimepoint: At any point till resolution of shock;Proportion requiring additional vasoactive agentsTimepoint: Till resolution of shock;Resolution of shock within 6 hours of resuscitationTimepoint: 6 hours;Time to achieve lactate below 2 mmol/L (defined as time from which arterial lactate remained below 2 mmol/L for at least 12hr)Timepoint: At any point