1612352 / KARE: Ketamine for reduction of Alcoholic Relapse Version 1
Worldwide, alcohol abuse is an escalating problem. In the UK 3.9 million adults suffer from alcohol dependence and annually around 22,000 people die from alcohol misuse. Consequences of prolonged alcohol abuse, both physically and psychologically, can be severe and costs the NHS £2.7 billion annually. Treating alcohol dependence and abstinence is key to the mental and physical recovery as well as reducing the burden on the NHS. Current treatments have high relapse rates of 70% after 6 months.
Preliminary evidence indicates that 3 doses of the anaesthetic drug, ketamine, combined with psychological therapy reduces the one year relapse rates by over 40%. However, this data is only supported from controlled laboratory studies and a small uncontrolled patient study. Our primary aim is to assess if ketamine therapy is safe, well-tolerated and effective in abstinence. We also aim to examine whether ketamine alone is as effective as ketamine plus psychological therapy. This MRC grant funded multi-site study will be run at 2 NHS Hospitals. There are 4 treatment arms.
We will randomise 96 detoxified alcoholics with mild depression to receive 3 weekly intravenous infusions of either ketamine or a placebo (saline). Participants will also be randomly allocated to receive either psychological therapy or educational control. There are 10 appointments over 6 months. At these visits, Vital signs will be checked, blood and urine samples taken and questionnaires and psychology and memory tests will be done. 3 of the visits will involve ketamine or placebo infusion.
Participants will also wear an ankle bracelet that measures alcohol usage for the trial duration. Prolonging abstinence in patients with alcohol dependency will improve their physical health, reduces life threatening related diseases and lessens the financial burdens on the NHS. We believe this may be better achieved with a package of psychotherapy and ketamine. (Study due to close 01/12/2018)
1703388 / PRISM
Introduction: Over 300 million patients undergo surgery worldwide each year with reported mortality of 1 – 4%. Morbidity and mortality are most frequent amongst high-risk patients who undergo major abdominal surgery. Respiratory complications, in particular pneumonia, are amongst the most frequent and severe. However, standard treatments, like physiotherapy or supplemental oxygen, often fail to prevent these. Preliminary research suggests that prophylactic continuous positive airways pressure (CPAP) can reduce the risk of respiratory complications after major surgery. However, without evidence from a large clinical effectiveness trial, CPAP has not been introduced into routine care. This trial aims to determine whether early postoperative CPAP reduces the incidence of respiratory complications and improves one-year survival following major intra-peritoneal surgery.
Methods and analysis: This is an international, multi-centre randomised controlled trial with open study group allocation, in European hospitals undertaking elective intra-peritoneal surgery. The participants are patients aged 50 years and over undergoing major elective intra-peritoneal surgery. The intervention is continuous positive airways pressure for at least four hours, started within four hours of the end of surgery. The primary outcome is a composite of pneumonia, re-intubation, or death within 30 days of randomisation. All participants with a recorded outcome will be analysed according to the treatment group to which they were randomised (intention-to-treat analysis). The primary outcome will be analysed using a mixed-effects logistic regression model, which includes centre as a random-intercept, and will be adjusted for the minimisation factors and other pre-specified baseline covariates.
Ethics and dissemination: The UK National Research Ethics Service has approved the protocol (15/LO/1595). Before starting recruitment, local approvals will be obtained for each site. (Study due to close 01/12/2018)
1708474 / Perioperative Quality Improvement Programme: Patient Study
This application is to gather and analyse patient data using the PQIP Database.
PQIP will measure complications after major planned surgery and seek to improve these outcomes through feedback of data to clinicians. A REC/CAG application for the PQIP Database has already received a favourable opinion. This analysis will answer important research questions about variation in quality of care in major surgery.
We expect that this substantial collaborative work will lead to valuable insights regarding the ways in which hospitals use data to drive improvements in care. (Study due to close 31/05/2020)
1810691 / DALES – Drug Allergy Labels in the Elective Surgical Population (DALES)
Self-reported drug allergies are common in the surgical population. Allergy labels are of particular concern for anaesthetists, whose patients are exposed to a wide range of drugs during the peri-operative period. Unfortunately, many of these labels are based on reactions not indicative of true allergy, but rather of side effects or other non-allergic phenomena. Allergy labels must be interpreted on the day of surgery, and may significantly influence peri-operative drug prescribing.
The avoidance of drugs due to an allergy label is potentially harmful, with important drugs unnecessarily avoided, and alternatives given which may be less effective and more toxic. A good example is the ‘penicillin allergy’ label. Around 10% of the population report penicillin allergy, but fewer than 5% of these will actually be allergic. Use of broad spectrum alternatives is detrimental to patients and healthcare services. Other examples relevant to anaesthesia include spurious allergy labels for opiates and non-steroidal pain killers; the impact of these has not been assessed previously.
We aim to define the prevalence of drug allergy labelling in the UK surgical population, and to determine the proportion of these labels which are likely to reflect true allergy.
For a sub-set of allergy labels, we will study their impact on perioperative
prescribing. We will also conduct an attitude and knowledge-based survey of anaesthetists, to explore understanding of drug allergies, the effect of allergy labels on prescribing habits, and ideas to help reduce the burden of inaccurate labelling in the future.
This study will consist of a patient questionnaire administered on the day of surgery, for three consecutive days, and a survey for all anaesthetists to complete. We hope to offer participation in the study to 18,000 patients from over 200 UK NHS sites, and more than 1000 anaesthetists. (Study due to close 02/07/2018)