Extrait

Background and study aims The drug methylnaltrexone is approved for use in the palliative/end of life care setting for treating constipation caused by opioid drugs. We believe that the use of methylnaltrexone for patients taking opioids will be of even greater benefit for people being treated in intensive care. Opioid drugs are used for the sedation and pain relief required for critically ill patients to tolerate mechanical breathing assistance. Unfortunately, there are considerable side effects including pruritus (itching), suppression of the immune system and most clinically relevant gastrointestinal (bowel) dysfunction. This leads to digestive problems, constipation leading to stomach bloating, a large immobile stool volume in the bowel (faecal impaction) and infection. There are several case reports supporting use of methylnaltrexone in intensive care , and we have used the drug successfully at Hammersmith Hospital. We have published a study showing that a significant number of critical care patients do suffer from opioid induced constipation despite standard treatment given to prevent this. Those patients that were treated with methylnaltrexone opened bowels within 24 hours, a result not achieved with standard therapy. There were also some benefits in the feeding and digestion of food and mortality (death rate) although these were not statistically significant. We now want to carry out a full trial to further investigate whether the drug methylnaltrexone does alleviate constipation caused by opioid drugs for critical care patients. Who can participate? Adults (aged at least 18) sedated with opiods and requiring mechanical breathing assistance. What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 receive methylnaltrexone following 48 hours of opioid induced constipation. Those in group 2 receive a placebo following 48 hours of opioid induced constipation. All participants are then followed up every day to assess, among other things, relief of constipation, tolerance of feeding, infection and mortality. What are the possible benefits and risks of participating? Methylnaltrexone has been shown to ease constipation in patients with cancer. It would be anticipated that critically ill patients would benefit too. In addition, there is the possibility of additional advantages in more effective feeding, and reversal of some of the detrimental immune effects of opioids. However, at the moment, we do not know if Methylnaltrexone definitely has these benefits or that the side effects will still be rare in this group of patients, which is why we are doing this study. We cannot guarantee taking part in the study will benefit a participant directly but if this study shows a benefit, then it might help improve the treatment of people with constipation and gut dysfunction in the future. There is little additional risk from taking part in this study, as Methylnaltrexone is very safe with few side effects (nausea, diarrhoea, flatulence, dizziness), and no serious adverse effects have been reported. Only very small quantities of extra blood samples will be collected, usually from existing lines, so there is no extra discomfort. Where is the study run from? Imperial College of Science, Technology and Medicine (UK) When is the study starting and how long is it expected to run for? May 2015 to April 2016 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Miss Aisha Anjum

Critère d'inclusion

• Topic: Critical care; Subtopic: Critical care; Disease: All Critical care

Liens

• isrctn
• ictrp