Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: a randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome

Gavin D Perkins, Simon Gates, Sarah E Lamb, Chris McCabe, Duncan Young, Fang Gao

Research output: Contribution to journalArticlepeer-review

17 Citations (Scopus)

Abstract

BACKGROUND: The acute respiratory distress syndrome (ARDS) is a common cause of respiratory failure in critically ill patients. Experimental studies suggest that treatment with beta agonists may be helpful in ARDS. The Beta Agonist Lung Injury TrIal (BALTI-2) is a multicentre, pragmatic, randomised, double-blind, placebo-controlled clinical trial which aims to determine if sustained treatment with intravenous (IV) salbutamol will improve survival in ARDS.

METHODS/DESIGN: Patients fulfilling the American-European Consensus Conference Definition of ARDS will be randomised in a 1:1 ratio to receive an IV infusion either of salbutamol (15 μg kg ideal body weight-1 hr-1) or placebo (0.9% sodium chloride solution), for a maximum of seven days. Allocation to randomised groups will use minimisation to ensure balance with respect to hospital of recruitment, age group (<64, 65-84, >85 years) and PaO2/FiO2 ratio (≤6.7, 6.8- 13.2, ≥13.3 kPa). Data will be recorded by participating ICUs until hospital discharge, and all surviving patients will be followed up by post at six and twelve months post randomisation. The primary outcome is mortality at 28 days after randomisation; secondary outcomes are mortality in ICU, mortality in hospital, number of ventilator-free days, number of organ failure-free days, mortality at twelve months post-randomisation, quality of life at six and twelve months, length of stay in ICU, length of stay in hospital, adverse effects (tachycardia, arrhythmia or other side effects sufficient to stop treatment drug). 1,334 patients will be recruited from about fifty ICUs in the UK. An economic evaluation will be conducted alongside the trial.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN38366450.

Original languageEnglish
Pages (from-to)113
JournalTrials
Volume12
DOIs
Publication statusPublished - 2011

Keywords

  • Adrenergic beta-2 Receptor Agonists
  • Albuterol
  • Cost-Benefit Analysis
  • Double-Blind Method
  • Drug Costs
  • Female
  • Great Britain
  • Hospital Costs
  • Hospital Mortality
  • Humans
  • Infusions, Intravenous
  • Intensive Care Units
  • Length of Stay
  • Male
  • Placebo Effect
  • Research Design
  • Respiration, Artificial
  • Respiratory Distress Syndrome, Adult
  • Survival Rate
  • Time Factors
  • Treatment Outcome

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