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Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial (MACANUDO)

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ClinicalTrials.gov Identifier: NCT03000413
Recruitment Status : Unknown
Verified December 2016 by Wagner Luis Nedel, Hospital Nossa Senhora da Conceicao.
Recruitment status was:  Recruiting
First Posted : December 22, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Wagner Luis Nedel, Hospital Nossa Senhora da Conceicao

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE December 22, 2016
Last Update Posted Date December 22, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2016)
  • Dynamic complacence improvement [ Time Frame: 3 hours and 24 hours post beginning of drug infusion ]
  • Air trapping improvement [ Time Frame: 3 hours and 24 hours post beginning of drug infusion ]
    intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion
  • Heart rate [ Time Frame: 3 hours and 24 hours post beginning of drug infusion ]
    Heart rate in 3 hours and 24h post beginning of drug infusion
  • Blood pressure [ Time Frame: 3 hours and 24 hours post beginning of drug infusion ]
    Blood pressure variation in 3 hours and 24hours post beginning of drug infusion
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Illness
  • Asthma
  • Bronchospasm
Intervention  ICMJE
  • Drug: Ketamine
    Active treatment
  • Drug: Fentanyl
Study Arms  ICMJE
  • Experimental: Ketamine
    Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)
    Intervention: Drug: Ketamine
  • Active Comparator: Fentanyl
    Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h)
    Intervention: Drug: Fentanyl
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03000413
Other Study ID Numbers  ICMJE 42324015.0.0000.5530
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wagner Luis Nedel, Hospital Nossa Senhora da Conceicao
Study Sponsor  ICMJE Hospital Nossa Senhora da Conceicao
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Nossa Senhora da Conceicao
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP