Beta Agonist Lung Injury TrIal (BALTI) Prevention Study
| ISRCTN | ISRCTN47481946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47481946 |
| Protocol serial number | N/A |
| Sponsor | Birmingham Heartlands Hospital (UK) |
| Funder | Department of Health (UK) - the Research Capacity Development (RCD) Programme (ref: PAS/02/06/RDA/010) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre double-blind randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Salmeterol |
| Primary outcome measure(s) |
The development of clinically significant acute lung injury within 72 hours of oesophagectomy. |
| Key secondary outcome measure(s) |
1. Global severity of illness at admission to Intensive Therapy Unit (ITU): Acute Physiology And Chronic Health Evaluation (APACHE II) |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 360 |
| 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
- United Kingdom
- England
Study participating centre
B9 5SS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/03/2014 | Yes | No | |
| Protocol article | protocol | 15/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
