Neck of femur Optimisation Therapy-Targeted Stroke volume
| ISRCTN | ISRCTN88284896 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88284896 |
| Secondary identifying numbers | 5165 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 05/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Iain Moppett
Scientific
Scientific
Nottingham University Hospitals NHS Trust
University Department of Anaesthesia
Nottingham
NG5 1PB
United Kingdom
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The use of LiDCO guided fluid administration in hip fracture surgery: a randomised interventional treatment trial |
| Study acronym | NOTTS |
| Study objectives | To investigate if using a LiDCO machine (a minimally invasive device that measures how well the heart is pumping blood around the body) to guide the amount of intravenous fluid a patient gets while having their fractured hip repaired under a spinal anaesthetic affects: 1. The time the patient spends in hospital 2. The time until the patient is medically well enough to be discharged from hospital As of 21/06/2011 the anticipated end date for this trial has been extended from 01/09/2010 to 01/08/2012. |
| Ethics approval(s) | Nottingham REC 1 approved on the 03/102008 (ref: 08AN004) |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery |
| Intervention | Optimisation of fluid balance using SV targetted boluses of intravenous gelofusine 250 ml over 5 minutes compared to a cohort group having their fluid balance according to best usual practise (i.e., at the discretion of the attending anaesthetist). Follow up length: 1 months Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure | To investigate if using a LiDCO machine (a minimally invasive device that measures how well the heart is pumping blood around the body) affects the time spent in hospital. Determined by the patients length of stay. |
| Secondary outcome measures | 1. To use the LiDCO machine to characterise any changes in blood pressure and the amount of blood pumped 2. To investigate if using a LiDCO machine in patients undergoing hip fracture surgery with a spinal anaesthetic 3. To characterise the changes in the way the heart and blood vessels work after a spinal anaesthetic Outcome measures are determined by the patients length of stay. Mortality with be compared at 30, 60 and 90 days. |
| Overall study start date | 01/01/2009 |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned sample size: 130; UK sample size: 130 |
| Key inclusion criteria | 1. Patients listed for surgical repair of fracture neck of femur under spinal anaesthesia 2. Aged greater than 60 years, either sex |
| Key exclusion criteria | 1. Planned general anaesthetic 2. Severe valvular heart disease previously shown on echocardiography (reduces reliability of monitor measurements) 3. Taking lithium (interferes with calibration of monitor) 4. Multiple injuries requiring operative management 5. Revision surgery or total hip arthroplasty for fractured neck of femur (a different patient/surgical population |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/08/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
Nottingham University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom
| Website | http://www.nuh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Charity
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol | 28/09/2011 | Yes | No | |
| Results article | results | 01/03/2015 | Yes | No |
Editorial Notes
05/12/2017: internal review.
