Beta Agonist Lung Injury TrIal (BALTI) Prevention Study
| ISRCTN | ISRCTN47481946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47481946 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/01/2008
- Registration date
- 29/02/2008
- Last edited
- 09/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gavin Perkins
Scientific
Scientific
Associate Clinical Professor
Department of Critical Care
2nd Floor
Lincoln House
Birmingham Heartlands Hospital
Birmingham
B9 5SS
United Kingdom
| G.D.Perkins@warwick.ac.uk |
Study information
| Study design | Multicentre double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Beta Agonist Lung Injury TrIal (BALTI) Prevention Study: a multicentre, double-blind, randomised, placebo-controlled trial |
| Study acronym | BALTI Prevention Study |
| Study objectives | Those recruited will be suffering from oesophageal cancer. They will be undergoing oesophagectomy and the surgical procedure will involve collapsing one lung. There is a high post-operative risk of acute lung injury. Hypothesis: Inhaled salmeterol prior to elective oesophagectomy will reduce the incidence of early acute lung injury. |
| Ethics approval(s) | South Birmingham Ethics Committee approved on the 15th November 2007 (ref: 07/H1207/233) |
| Health condition(s) or problem(s) studied | Oesophageal cancer |
| Intervention | Inhaled salmeterol (100 µg) via spacer immediately prior to surgery, and then afterwards twice daily for 72 hours, versus placebo inhaler. If the patient is ventilated the drug will be given through the inspiratory limb of the ventilator. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Salmeterol |
| Primary outcome measure | The development of clinically significant acute lung injury within 72 hours of oesophagectomy. |
| Secondary outcome measures | 1. Global severity of illness at admission to Intensive Therapy Unit (ITU): Acute Physiology And Chronic Health Evaluation (APACHE II) 2. Severity of respiratory illness (partial pressure of oxygen in arterial blood [PaO2]:Fraction of inspired Oxygen [FiO2] ratio) daily for duration of intensive care unit (ITU)/high dependency unit (HDU) stay 3. Development of acute lung injury/acute respiratory distress syndrome (ARDS) at day 0 - 28 4. Ventilator free days 5. Organ failure free days 6. 28 and 90 day survival 7. Health related quality of life (EQ-5D) at baseline and at 28 and 90 days |
| Overall study start date | 01/03/2008 |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 216 (increased to 360 as of 18/06/2009) |
| Key inclusion criteria | 1. Planned elective transthoracic oesophagectomy patients 2. Aged greater than 18 years 3. Male and female 4. Able to provide informed consent 5. Able to use a spacer device to deliver the drug |
| Key exclusion criteria | 1. Pregnancy 2. Current treatment with long acting beta agonist 3. Allergy to excipients in salmeterol 4. Current treatment with non-cardioselective beta-blockers 5. Treatment with investigational medicinal product (IMP) in the last 30 days |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Associate Clinical Professor
Birmingham
B9 5SS
United Kingdom
B9 5SS
United Kingdom
Sponsor information
Birmingham Heartlands Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Liz Adey
Bordesley Green East
Birmingham
B9 5SS
England
United Kingdom
| Liz.Adey@heartofengland.nhs.uk | |
"ROR" |
https://ror.org/01bd5gh54 |
Funders
Funder type
Government
Department of Health (UK) - the Research Capacity Development (RCD) Programme (ref: PAS/02/06/RDA/010)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/03/2011 | Yes | No | |
| Results article | results | 15/03/2014 | Yes | No |
