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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Beta Agonist Lung Injury TrIal (BALTI) Prevention Study |
| Source of record | UK Trials |
| ISRCTN | ISRCTN47481946 |
| Date ISRCTN assigned | 29/02/2008 |
| Local reference number(s) | N/A |
| Public title | Beta Agonist Lung Injury TrIal (BALTI) Prevention Study |
| Scientific title | |
| Acronym | BALTI Prevention Study |
| Disease/condition/study domain | Oesophageal cancer |
| Study hypothesis | 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. |
| Design/methodology | Multi-centre, double-blind, randomised, placebo-controlled trial. |
| Research ethics review | South Birmingham Ethics Committee, Osprey House, 1 Albert Street, Redditch, Worcestershire, B97 4DE, UK. Approved on 15 November 2007 (ref: 07/H1207/233) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Planned elective transthoracic oesophagectomy patients 2. Aged >18 years 3. Male and Female 4. Able to provide informed consent 5. Able to use a spacer device to deliver the drug |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 01/03/2011 |
| Status of trial | Ongoing |
| Target number of participants | 216 |
| Interventions | Inhaled salmeterol (100 mcg) 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. |
| Primary outcome measure(s) | The development of clinically significant acute lung injury within 72 hours of oesophagectomy. |
| Secondary outcome measure(s) | 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 (PaO2:FiO2 ratio) daily for duration of ITU/High Dependency Unit (HDU) stay 3. Development of acute lung injury/Acute Respiratory Distress Syndrome (ARDS) 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) baseline and at 28 and 90 days |
| Sources of funding | Department of Health, the Research Capacity Development (RCD) Programme (PAS/02/06/RDA/010) (UK) |
| Sponsor name | Birmingham Heartlands Hospital (UK) |
| Sponsor details | c/o Dr Liz Adey Bordesley Green East Birmingham United Kingdom B9 5SS |
| Sponsor email | Liz.Adey@heartofengland.nhs.uk |
| Contact name | Dr Gavin Perkins |
| Contact details | Associate Clinical Professor Department of Critical Care 2nd Floor Lincoln House Birmingham Heartlands Hospital Birmingham United Kingdom B9 5SS |
| Contact email | gavin.perkins@virgin.net |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN47481946 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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