Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Active treatment
  • Fentanyl (DRUG)
    N/A

Condition or Disease

  • Critical Illness
  • Asthma
  • Bronchospasm

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 90 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2015
    Primary Completion: Jan 01, 2017 ESTIMATED
    Completion Date: Dec 01, 2017 ESTIMATED
    Study First Posted: Dec 22, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 19, 2016

    Sponsors / Collaborators

    Lead Sponsor: Hospital Nossa Senhora da Conceicao
    Responsible Party: N/A

    Location

    Porto Alegre, Brazil

    Participant Groups

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

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

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    • Maximal airway resistance reduction in hour 3-post beginning of drug infusion

    Secondary Outcomes

    • Maximal airway resistance reduction in 24th hour post beginning of drug infusion

    • Time (in days) to first spontaneous breathing trial post randomization up to 28 days

    Other Outcomes
    • Dynamic complacence improvement 3 hours and 24 hours post beginning of drug infusion

    • intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion

    • Heart rate in 3 hours and 24h post beginning of drug infusion

    • Blood pressure variation in 3 hours and 24hours post beginning of drug infusion

    More Details

    NCT Number: NCT03000413
    Acronym: MACANUDO
    Other IDs: 42324015.0.0000.5530
    Study URL: https://clinicaltrials.gov/study/NCT03000413
    Last updated: Sep 29, 2023