THERAPEUTIC EFFECT OF KETAMINE NEBULIZATION IN ACUTE RESPIRATORY DISTRESS SYNDROME: A RANDOMIZED CONTROLLED TRIAL
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To study the therapeutic effect of ketamine nebulization in ARDS based on Murray Score.
Study Overview
Brief Summary
The aim of study is to estimate the effect of ketamine nebulization in Acute Respiratory Distress Syndrome (ARDS). In this study, 20-50 years old, mechanically ventilated adult patients admitted to the ICU with diagnosis of ARDS (based on Berlin’s criteria) would be included.
The patients will be divided into two groups-
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Group K will be treated with 0.75 mg/kg ketamine (diluted in normal saline to make volume of 5 ml) nebulization 3 times a day in addition to standard treatment of ARDS
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Group C will receive Conventional therapy with nebulization with 5 ml normal saline 3 times a day in addition to standard treatment of ARDS.
The following parameters will be recorded : - Demographic data; APACHE Score at the time of admission; Daily SOFA sco; Daily P/F ratio; Murray Score; IL-6 level on Day 1,3 and 5; 28 days mortality; Sedative requirement; Vasopressor requirement(if any).
Patient will receive therapy uptill - Maximum for 5 days,Or PaO2/FiO2 ≥300, Or patient expires.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 20-50 years Mechanically ventilated adult patients admitted to the ICU with developing ARDS.
Exclusion Criteria
- •Pregnant women Patient/Attendant not giving consent Underlying cardiac, and neurological disorders Previous history of psychiatric disorder / substance abuse APACHE Score ≥25 Patient expiring within 3 days of initiation of therapy.
Outcomes
Primary Outcomes
To study the therapeutic effect of ketamine nebulization in ARDS based on Murray Score.
Time Frame: 28 Days
Secondary Outcomes
- To evaluate effect of ketamine nebulization on 28 days mortality in ARDS patients(28 days)
- To evaluate the effect of ketamine nebulization on IL-6 levels in ARDS patients on Day 1, 3 & 5.(5 days)
Investigators
AMNA KHATOON
KING GEORGE MEDICAL UNIVERSITY, LUCKNOW