NCT03000413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2018

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

November 18, 2016

Last Update Submit

May 17, 2024

Conditions

Critical IllnessAsthmaBronchospasm

Outcome Measures

Primary Outcomes (1)

  • bronchospasm improvement

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

    3 hours post beginning of drug infusion

Secondary Outcomes (2)

  • bronchospasm improvement

    24 hours post beginning of drug infusion

  • Time to weaning

    Time (in days) to first spontaneous breathing trial post randomization up to 28 days

Other Outcomes (4)

  • Dynamic complacence improvement

    3 hours and 24 hours post beginning of drug infusion

  • Air trapping improvement

    3 hours and 24 hours post beginning of drug infusion

  • Heart rate

    3 hours and 24 hours post beginning of drug infusion

  • +1 more other outcomes

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Drug: Ketamine

Fentanyl

ACTIVE COMPARATOR

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

Drug: Fentanyl

Interventions

KetamineDRUG

Active treatment

Ketamine
FentanylDRUG
Fentanyl

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nossa Senhora da Conceição

Porto Alegre, Brazil

Location

Related Publications (8)

  • 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.

    PMID: 25028944BACKGROUND

  • 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.

    PMID: 21716106BACKGROUND

  • 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.

    PMID: 17301376BACKGROUND

  • 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.

    PMID: 8629747BACKGROUND

  • 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.

    PMID: 24082612BACKGROUND

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

    PMID: 21730929BACKGROUND

  • 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.

    PMID: 23208583BACKGROUND

  • 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.

    PMID: 15988425BACKGROUND

MeSH Terms

Conditions

Critical IllnessAsthmaBronchial Spasm

Interventions

KetamineFentanyl

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc.

Study Record Dates

First Submitted

November 18, 2016

First Posted

December 22, 2016

Study Start

June 4, 2015

Primary Completion

June 16, 2017

Study Completion

January 29, 2018

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations

BR(1)