CClinicalTrials.gg
Sign In
CompletedNCT03000413MACANUDOUpdated May 21, 2024

Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

A Phase 2/3 interventional study of Ketamine and Fentanyl in Critical Illness, Asthma and Bronchospasm, sponsored by Hospital Nossa Senhora da Conceicao. Completed at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Hospital Nossa Senhora da Conceicao · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Critical Illness
  • Asthma
  • Bronchospasm
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Ketamine

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

    Drug: Ketamine

  • Active comparator
    Fentanyl

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

    Drug: Fentanyl

Interventions

  • DrugKetamine

    Active treatment

  • DrugFentanyl
05

What researchers measure

Primary outcomes

  1. bronchospasm improvement

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

    Time frame: 3 hours post beginning of drug infusion

Secondary outcomes

  1. bronchospasm improvement

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

    Time frame: 24 hours post beginning of drug infusion

  2. Time to weaning

    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 outcomes

  1. Dynamic complacence improvement

    Time frame: 3 hours and 24 hours post beginning of drug infusion

  2. Air trapping improvement

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

    Time frame: 3 hours and 24 hours post beginning of drug infusion

  3. Heart rate

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

    Time frame: 3 hours and 24 hours post beginning of drug infusion

  4. Blood pressure

    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

06

Study locations

1 site
  • Hospital Nossa Senhora da Conceição
    Porto Alegre, Brazil
07

References and documents

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 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. PubMed 25028944 ↗
  • 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. PubMed 21716106 ↗
  • 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. PubMed 17301376 ↗
  • 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. PubMed 8629747 ↗
  • 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. PubMed 24082612 ↗
  • Miller AC, Jamin CT, Elamin EM. Continuous intravenous infusion of ketamine for maintenance sedation. Minerva Anestesiol. 2011 Aug;77(8):812-20. PubMed 21730929 ↗
  • 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. PubMed 23208583 ↗
  • Allen JY, Macias CG. The efficacy of ketamine in pediatric emergency department patients who present with acute severe asthma. Ann Emerg Med. 2005 Jul;46(1):43-50. doi: 10.1016/j.annemergmed.2005.02.024. PubMed 15988425 ↗
08

Registry details

Key details

Study ID
NCT03000413
Lead sponsor
Hospital Nossa Senhora da Conceicao
Responsible party
Wagner Luis Nedel (MD, MSc., Hospital Nossa Senhora da Conceicao) — Principal investigator
First posted
Dec 22, 2016
Start date
Jun 4, 2015
Primary completion
Jun 16, 2017
Completion
Jan 29, 2018
Last update
May 21, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Bronchial Spasm→

Other studies from this sponsor

Hospital Nossa Senhora da Conceicao

Start the discussion