Clinical trial NCT03000413: Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial
Official title: Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Critical Illness
Asthma
Bronchospasm
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite few scientific evidence that could support the use of ketamine in adult patients undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely employed in this setting. The aim of this study is therefore assess more definitively the real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and need for MV in order to establish or refute the use of this drug as "standard therapy" in these cases.


Eligibility criteria: Inclusion Criteria:

* patients with acute exacerbation of COPD or status asthmaticus, undergoing controlled mechanical ventilation
* acute bronchospasm, defined as airway resistance value (Rsr max) greater than 12, use of inhaled therapy with bronchodilators and systemic corticosteroids
* patients requiring the use of continuous intravenous sedation for optimization of ventilation

Exclusion Criteria:

* contraindication or history of previous adverse events with the use of the studied drugs
* other diagnostic potential Rsr increase of not causing bronchospasm (bronchial obstruction, acute respiratory distress syndrome adult, pulmonary fibrosis)

Primary outcomes:
measure: bronchospasm improvement
timeFrame: 3 hours post beginning of drug infusion
Secondary outcomes:
measure: bronchospasm improvement
timeFrame: 24 hours post beginning of drug infusion
measure: Time to weaning
timeFrame: Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Other outcomes:
measure: Dynamic complacence improvement
timeFrame: 3 hours and 24 hours post beginning of drug infusion
measure: Air trapping improvement
timeFrame: 3 hours and 24 hours post beginning of drug infusion
measure: Heart rate
timeFrame: 3 hours and 24 hours post beginning of drug infusion
measure: Blood pressure
timeFrame: 3 hours and 24 hours post beginning of drug infusion
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
Study officials:
References:
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