HIPHOP pilot study
Research type
Research Study
Full title
Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) Trial: Pilot Study\n
IRAS ID
190244
Contact name
Iain Moppett
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN89812075
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Low blood pressure (hypotension) around the time of surgery is one such outcome. National audit data has shown that episodes of hypotension are very common (~90%) in hip fracture patients and, when severe (~30%), are associated with increased death rates, possibly related to decreased blood flow to the brain (causing delirium), heart (causing heart rhythm and pumping abnormalities), lungs (causing postoperative pulmonary complications) and kidneys (causing kidney injury) after surgery. Alternatively, those patients whose blood pressure falls more, may be those with greater co-existing illness and frailty and therefore more likely to have a poor outcome, regardless of intervention.\nThe aim of this study is to see whether reducing the amount of hypotension (number, severity and duration of episodes) during anaesthesia for hip fracture surgery decreases the frequency of delirium, heart abnormalities and kidney failure within five days after the operation. e will randomly allocate eligible participants into one of two groups. A control group will receive standard care. The intervention group will have their blood pressure will be monitored and treated more rigorously according to a predetermined protocol, which describes acceptable blood pressure limits and treatment options involving intravenous fluids and drugs to increase blood pressure. \nWe will include all patients over the age of 70 with a single broken hip who are able to consent to participation, requiring any type of hip fracture surgery. Validated assessment tools will be used to determine whether or not one or more of the clinical outcomes we are interested in have occurred in the five days after surgery. \n\tThis is a pilot phase of this study, so that we can further refine the number of participants required in total and resolve any problems with our intended methods; data from pilot participants will be included in the full study.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
16/EM/0036
Date of REC Opinion
13 Apr 2016
REC opinion
Further Information Favourable Opinion