Extrait

Background and study aims Overwhelming infection (severe sepsis) can lead to a drop in blood pressure. This results in poor blood flow to the kidney and other vital organs. Severe infections are becoming an increasing healthcare problem. It is the 10th most common cause of death in America and it is estimated that the UK spends more than £1 billion each year treating severe infections in patients in intensive care units (ICU). As well as antibiotics and intravenous fluids, adrenaline-type drugs are routinely used to increase blood pressure. Although usually effective at restoring blood pressure these drugs have important side effects. Vasopressin and steroids are both naturally produced hormones that are released during times of severe illness. However, when blood pressure drops due to infection, these compensatory mechanisms often fail. Studies have shown that administering both of these drugs can help restore blood pressure and reduce the use of other adrenaline-type drugs. Recent studies found that vasopressin may be most effective if used earlier and for less severe drops in blood pressure and may have a specific role in preventing kidney failure. It may also be more effective if administered with steroids. We plan to undertake a trial to investigate if vasopressin can reduce kidney failure and the need for dialysis in patients with severe infections. We also plan to investigate if steroids cross-react with vasopressin. Who can participate? This study aims to recruit 412 adult patients with septic shock, being treated in 19 intensive care units (ICU) in the UK. What does the study involve? All patients who are clinically judged to have septic shock will be screened against the inclusion and exclusion criteria to see if they are eligible for the study. The patients will be randomised to receive either Vasopressin or Noradrenaline (Study Drug 1) by continuous infusion to stabilise their blood pressure. If the maximum limit of Study Drug 1 is reached then Study Drug 2 (hydrocortisone or placebo) will be administered. Routinely collected clinical data will be recorded on a daily basis during this time. Additional blood and urine samples will also be collected from a subset of patients on days 1, 3, 5 and 7 of the trial. Patients will be followed up at 28 days after inclusion and / or hospital discharge. What are the possible benefits and risks of participating? It is possible that one of the combinations of these drugs is better that then the other combinations. At the moment we do not know which combination is best. This study might help improve the treatment of people with septic shock in the future. As all the study drugs are already routinely used in the management of septic shock there is minimal extra risk from participation in this study. The doctors and nurses will watch careful for any possible side-effects and will treat them as necessary and even stop the drugs if needed. Only very small quantities of extra blood samples will be collected, usually from existing lines, but it might be necessary to collect a sample from a new needle which might result in some minor discomfort during collection and possibly a small bruise. Where is the study run from? The VANISH trial will run from Charing Cross Hospital, part of Imperial College London. When is study starting and how long is it expected to run for? It is anticipated that recruitment will start in November 2012. Participants will be recruited into the study over a period of 30 months. Who is funding the study? Funding has been provided by NIHR (National Institute for Health Research) - Research for Patient Benefit and Clinical Scientist award schemes. Who is the main contact? Mrs Neeraja Thirunavukkarasu [email protected]

Critère d'inclusion

• Topic: Infection, Generic Health Relevance and Cross Cutting Themes; Subtopic: Infection (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Infectious diseases and microbiology , Critical Care

Liens

• isrctn
• ictrp