Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-04

Study Completion Date

2018-01-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Critical Illness Asthma Bronchospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Ketamine

Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Active treatment

Fentanyl

Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h)

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Interventions

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Ketamine

Active treatment

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No