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Completed

NCT Number: NCT03000413

Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO 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.

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Key information

Conditions

Critical Illness Asthma Bronchial Diseases Bronchial Spasm Bronchospasm Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Nossa Senhora da Conceição

Porto Alegre, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ketamine

Drug

Active treatment

Fentanyl

Drug

Primary outcomes

  1. bronchospasm improvement

    Time frame: 3 hours post beginning of drug infusion

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

Secondary outcomes

  1. bronchospasm improvement

    Time frame: 24 hours post beginning of drug infusion

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

  2. Time to weaning

    Time frame: 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

Other outcomes

  1. Dynamic complacence improvement

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

  2. Air trapping improvement

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

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

  3. Heart rate

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

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

  4. Blood pressure

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

    Blood pressure variation in 3 hours and 24hours post beginning of drug infusion

Sponsors and collaborators

Lead sponsor

Hospital Nossa Senhora da Conceicao

Other

Registry information

Official study title

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

Acronym: MACANUDO

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 22, 2016
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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