Clinical Trial: Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial

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 Summary:
Sponsor: Hospital Nossa Senhora da Conceicao

Current Primary Outcome: bronchospasm improvement [ Time Frame: 3 hours post beginning of drug infusion ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • bronchospasm improvement [ Time Frame: 24 hours post beginning of drug infusion ]
    Maximal airway resistance reduction in 24th hour post beginning of drug infusion
  • Time to weaning [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Hospital Nossa Senhora da Conceicao

Dates:
Date Received: November 18, 2016
Date Started: August 2015
Date Completion: December 2017
Last Updated: December 19, 2016
Last Verified: December 2016