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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

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.

Condition or disease Intervention/treatment Phase
Critical Illness Asthma Bronchospasm Drug: Ketamine Drug: Fentanyl Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial
Study Start Date : August 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketamine
Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)
Drug: Ketamine
Active treatment

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



Primary Outcome Measures :
  1. bronchospasm improvement [ Time Frame: 3 hours post beginning of drug infusion ]
    Maximal airway resistance reduction in hour 3-post beginning of drug infusion


Secondary Outcome Measures :
  1. bronchospasm improvement [ Time Frame: 24 hours post beginning of drug infusion ]
    Maximal airway resistance reduction in 24th hour post beginning of drug infusion

  2. 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


Other Outcome Measures:
  1. Dynamic complacence improvement [ Time Frame: 3 hours and 24 hours post beginning of drug infusion ]
  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000413


Contacts
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Contact: Wagner Nedel, MD, MSc +555133572237 wagnernedel@uol.com.br

Locations
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Brazil
Hospital Nossa Senhora da Conceição Recruiting
Porto Alegre, Brazil
Contact: Wagner Nedel, MD, MSc       wagnernedel@uol.com.br   
Sponsors and Collaborators
Hospital Nossa Senhora da Conceicao
Publications:
Barbas CS, Isola AM, Farias AM, Cavalcanti AB, Gama AM, Duarte AC, Vianna A, Serpa Neto A, Bravim Bde A, Pinheiro Bdo V, Mazza BF, Carvalho CR, Toufen Júnior C, David CM, Taniguchi C, Mazza DD, Dragosavac D, Toledo DO, Costa EL, Caser EB, Silva E, Amorim FF, Saddy F, Galas FR, Silva GS, Matos GF, Emmerich JC, Valiatti JL, Teles JM, Victorino JA, Ferreira JC, Prodomo LP, Hajjar LA, Martins LC, Malbouisson LM, Vargas MA, Reis MA, Amato MB, Holanda MA, Park M, Jacomelli M, Tavares M, Damasceno MC, Assunção MS, Damasceno MP, Youssef NC, Teixeira PJ, Caruso P, Duarte PA, Messeder O, Eid RC, Rodrigues RG, Jesus RF, Kairalla RA, Justino S, Nemer SN, Romero SB, Amado VM. Brazilian recommendations of mechanical ventilation 2013. Part I. Rev Bras Ter Intensiva. 2014 Apr-Jun;26(2):89-121. Review. English, Portuguese.

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Responsible Party: Wagner Luis Nedel, MD, MSc., Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier: NCT03000413    
Other Study ID Numbers: 42324015.0.0000.5530
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Bronchial Spasm
Critical Illness
Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Fentanyl
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia