Cerebrospinal fluid in delirium after hip fracture extension study

• Research type

  Research Study

• Full title

  Cerebrospinal fluid in delirium after hip fracture extension study

• IRAS ID

  163564

• Contact name

  Roanna J Hall

• Sponsor organisation

  University of Edinburgh

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  An observational study was undertaken from September 2009 to May 2012 examining the role of the stress hormone cortisol, markers of inflammation and brain damage markers in delirium (acute confusion) after hip fracture. One-hundred and eight elderly participants were recruited and followed-up for one year. If patients had a spinal anaesthetic performed at the time of their hip fracture repair, a sample of cerebrospinal fluid (CSF), which bathes the brain and spinal cord, was collected at the time the anaesthetic needle was inserted for this necessary procedure. Blood samples were collected before the operation and 4 and 10-14 days later, and at follow-up visits. During the original study, we had consent to store these CSF and blood samples anonymously for five years and to perform future research using them, excluding studies involving DNA. This study has a very rich and detailed dataset on a frail population with a high rate of delirium, a condition which is poorly understood and has significant negative outcomes. The samples collected and currently in storage are unusual and precious, and there is great potential to make further discoveries in the field of delirium mechanisms, in addition to the four existing publications which have already added to this small yet important area of research. The original ethics and R&D are lapsing for this study. We would like to ask the committee to please give an opinion on whether it is ethical to store the samples for a longer time period, and perform further tests on them to learn more about delirium. These tests would include amino acids, markers of oxidative stress and other biomarkers. We would also like to collect data from public records on the participants' dates of death after the year follow-up finished, to strengthen the predictive value of the biomarkers for negative outcomes.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  15/NW/0947

• Date of REC Opinion

  1 Dec 2015

• REC opinion

  Favourable Opinion