Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Asthma Clinical Trial

— MACANUDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000413
• Other study ID #: 42324015.0.0000.5530
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 18, 2016
• Last updated: December 19, 2016
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Hospital Nossa Senhora da Conceicao
• Contact: Wagner Nedel, MD, MSc
• Phone: +555133572237
• Email: wagnernedel[@]uol.com.br
• Is FDA regulated: No
• Health authority: "Brasil: Comissão Nacional de Ética em Pesquisa"
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Spasm
• Bronchospasm
• Critical Illness

Intervention

Drug:
• Ketamine
Active treatment
• Fentanyl

Locations

Country	Name	City	State
Brazil	Hospital Nossa Senhora da Conceição	Porto Alegre

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nossa Senhora da Conceicao

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View Citation

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. — View 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 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. — View 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. Review. — View 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. — View 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. — View Citation

Miller AC, Jamin CT, Elamin EM. Continuous intravenous infusion of ketamine for maintenance sedation. Minerva Anestesiol. 2011 Aug;77(8):812-20. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dynamic complacence improvement		3 hours and 24 hours post beginning of drug infusion	No
Other	Air trapping improvement	intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion	3 hours and 24 hours post beginning of drug infusion	No
Other	Heart rate	Heart rate in 3 hours and 24h post beginning of drug infusion	3 hours and 24 hours post beginning of drug infusion	Yes
Other	Blood pressure	Blood pressure variation in 3 hours and 24hours post beginning of drug infusion	3 hours and 24 hours post beginning of drug infusion	Yes
Primary	bronchospasm improvement	Maximal airway resistance reduction in hour 3-post beginning of drug infusion	3 hours post beginning of drug infusion	No
Secondary	bronchospasm improvement	Maximal airway resistance reduction in 24th hour post beginning of drug infusion	24 hours post beginning of drug infusion	No
Secondary	Time to weaning	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	No