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Early Adrenaline versus placebo in children with low blood pressure due to sepsis: A Placebo Controlled Blinded Randomised Clinical Trial

Early Epinephrine Vs Standard Care For Pediatric Hypotensive Septic Shock: A Placebo Controlled Blinded Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025078
Enrollment
190
Registered
2020-05-08
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: I958- Other hypotension

Interventions

Intervention1: Epinephrine: For paediatric hypotensive septic shock - Drug - Epinephrine, Route - Continuous IV infusion prepared in normal saline solution, Dose - 0.1µg/Kg/Min that will be administ

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 12 years or younger admitted with hypotensive septic shock

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Length 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

Countries

India

Contacts

Public ContactKarthi N

Postgraduate Institute of Medical Education and Research

ny.karthi@gmail.com9814376716

Outcome results

None listed

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