Critical IllnessPhase 2/3MACANUDONCT03000413
Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial
A Phase 2/3 study testing Ketamine and Fentanyl in people with Critical Illness and Asthma, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Critical Illness, Asthma, Bronchospasm
- What is being tested?
- Ketamine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jun 2015to 29 Jan 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial
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.
- Conditions
- Critical Illness, Asthma, Bronchospasm
- Medical subject headings
- Critical Illness, Asthma, Bronchial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h) Receives: Drug: Ketamine |
| Fentanyl | Active comparator | Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h) Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchospasm improvement
Maximal airway resistance reduction in hour 3-post beginning of drug infusion
Measured: 3 hours post beginning of drug infusion
Secondary outcomes (2)
bronchospasm improvement
Maximal airway resistance reduction in 24th hour post beginning of drug infusion
Measured: 24 hours post beginning of drug infusion
Time to weaning
Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Measured: Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start4 Jun 2015
- Primary completion16 Jun 2017
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wagner Luis Nedel, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000413
- Sponsor's protocol ID
- 42324015.0.0000.5530
- Acronym
- MACANUDO
- Status last verified
- May 2024
- First submitted
- 18 Nov 2016
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
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 25028944Rowe 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 21716106Heshmati 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 17301376Howton 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 8629747Goyal 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 24082612Miller AC, Jamin CT, Elamin EM. Continuous intravenous infusion of ketamine for maintenance sedation. Minerva Anestesiol. 2011 Aug;77(8):812-20.
PubMed 21730929Abu-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 23208583Allen 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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03000413
- Acronym / sponsor ID
- MACANUDO / 42324015.0.0000.5530
- Conditions
- Critical Illness, Asthma, Bronchospasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 4 Jun 2015 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineIntravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h) |
| Fentanyl | Active comparator | Drug: FentanylFentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineActive treatment | Drug | Ketamine |
| Fentanyl | Drug | Fentanyl |
Primary outcome
bronchospasm improvement
Time frame: 3 hours post beginning of drug infusion
Maximal airway resistance reduction in hour 3-post beginning of drug infusion
2 secondary outcomes
bronchospasm improvement
Time frame: 24 hours post beginning of drug infusion
Time to weaning
Time frame: Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 25028944Barbas 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.
- Background: PubMed 21716106Rowe 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.
- Background: PubMed 17301376Heshmati 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.
- Background: PubMed 8629747Howton 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.
- Background: PubMed 24082612Goyal 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.
- Background: PubMed 21730929Miller AC, Jamin CT, Elamin EM. Continuous intravenous infusion of ketamine for maintenance sedation. Minerva Anestesiol. 2011 Aug;77(8):812-20.
- Background: PubMed 23208583Abu-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.
- Background: PubMed 15988425Allen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine and Fentanyl in people with Critical Illness and Asthma, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bronchospasm improvement (time frame: 3 hours post beginning of drug infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000413, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.