Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Phase 2

Completed

• Conditions: Asthma; Bronchospasm; Critical Illness
• Interventions: Drug: Fentanyl; Drug: Ketamine

• Registration Number: NCT03000413
• Lead Sponsor: Hospital Nossa Senhora da Conceicao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-04
• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-22
• Primary Completion: 2017-06-16
• Study Completion: 2018-01-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl	Fentanyl	Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h)
Ketamine	Ketamine	Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)

Primary Outcome Measures

Name	Time	Method
bronchospasm improvement	3 hours post beginning of drug infusion	Maximal airway resistance reduction in hour 3-post beginning of drug infusion

Secondary Outcome Measures

Name	Time	Method
Time to weaning	Time (in days) to first spontaneous breathing trial post randomization up to 28 days	Time (in days) to first spontaneous breathing trial post randomization up to 28 days
bronchospasm improvement	24 hours post beginning of drug infusion	Maximal airway resistance reduction in 24th hour post beginning of drug infusion

Trial Locations

Locations (1)

Hospital Nossa Senhora da Conceição; 🇧🇷 Porto Alegre, Brazil