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

Primary Purpose

Critical Illness, Asthma, Bronchospasm

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ketamine
Fentanyl
Sponsored by
Hospital Nossa Senhora da Conceicao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital Nossa Senhora da ConceiçãoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine

Fentanyl

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2016
Last Updated
December 19, 2016
Sponsor
Hospital Nossa Senhora da Conceicao
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1. Study Identification

Unique Protocol Identification Number
NCT03000413
Brief Title
Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial
Acronym
MACANUDO
Official Title
Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nossa Senhora da Conceicao

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Asthma, Bronchospasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h)
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Active treatment
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Primary Outcome Measure Information:
Title
bronchospasm improvement
Description
Maximal airway resistance reduction in hour 3-post beginning of drug infusion
Time Frame
3 hours post beginning of drug infusion
Secondary Outcome Measure Information:
Title
bronchospasm improvement
Description
Maximal airway resistance reduction in 24th hour post beginning of drug infusion
Time Frame
24 hours post beginning of drug infusion
Title
Time to weaning
Description
Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Time Frame
Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Other Pre-specified Outcome Measures:
Title
Dynamic complacence improvement
Time Frame
3 hours and 24 hours post beginning of drug infusion
Title
Air trapping improvement
Description
intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion
Time Frame
3 hours and 24 hours post beginning of drug infusion
Title
Heart rate
Description
Heart rate in 3 hours and 24h post beginning of drug infusion
Time Frame
3 hours and 24 hours post beginning of drug infusion
Title
Blood pressure
Description
Blood pressure variation in 3 hours and 24hours post beginning of drug infusion
Time Frame
3 hours and 24 hours post beginning of drug infusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wagner Nedel, MD, MSc
Phone
+555133572237
Email
wagnernedel@uol.com.br
Facility Information:
Facility Name
Hospital Nossa Senhora da Conceição
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wagner Nedel, MD, MSc
Email
wagnernedel@uol.com.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
25028944
Citation
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 Junior 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, Assuncao 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. doi: 10.5935/0103-507x.20140017.
Results Reference
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PubMed Identifier
21716106
Citation
Rowe BH, Sevcik W, Villa-Roel C. Management of severe acute asthma in the emergency department. Curr Opin Crit Care. 2011 Aug;17(4):335-41. doi: 10.1097/MCC.0b013e328348bf09.
Results Reference
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PubMed Identifier
17301376
Citation
Heshmati F, Zeinali MB, Noroozinia H, Abbacivash R, Mahoori A. Use of ketamine in severe status asthmaticus in intensive care unit. Iran J Allergy Asthma Immunol. 2003 Dec;2(4):175-80.
Results Reference
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PubMed Identifier
8629747
Citation
Howton JC, Rose J, Duffy S, Zoltanski T, Levitt MA. Randomized, double-blind, placebo-controlled trial of intravenous ketamine in acute asthma. Ann Emerg Med. 1996 Feb;27(2):170-5. doi: 10.1016/s0196-0644(96)70319-0.
Results Reference
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PubMed Identifier
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Citation
Goyal S, Agrawal A. Ketamine in status asthmaticus: A review. Indian J Crit Care Med. 2013 May;17(3):154-61. doi: 10.4103/0972-5229.117048.
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PubMed Identifier
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Citation
Miller AC, Jamin CT, Elamin EM. Continuous intravenous infusion of ketamine for maintenance sedation. Minerva Anestesiol. 2011 Aug;77(8):812-20.
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PubMed Identifier
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Abu-Hijleh M, El-Sameed Y, Eldridge K, Vadia E, Chiu H, Dreyfuss Z, Al Rabadi LS. Linear probe endobronchial ultrasound bronchoscopy with guided transbronchial needle aspiration (EBUS-TBNA) in the evaluation of mediastinal and hilar pathology: introducing the procedure to a teaching institution. Lung. 2013 Feb;191(1):109-15. doi: 10.1007/s00408-012-9439-z. Epub 2012 Dec 4.
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Results Reference
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Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

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