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ISRCTN
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ISRCTN88284896
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ClinicalTrials.gov identifier
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Public title
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Neck of femur Optimisation Therapy-Targeted Stroke volume
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Scientific title
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The use of LiDCO guided fluid administration in hip fracture surgery: a randomised interventional treatment trial
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Acronym
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NOTTS
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Serial number at source
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5165
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Nottingham REC 1 approved on the 03/102008 (ref: 08AN004)
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Study design
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Randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery
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Participants - inclusion criteria
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1. Patients listed for surgical repair of fracture neck of femur under spinal anaesthesia
2. Aged greater than 60 years, either sex
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2009
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Anticipated end date
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01/08/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 130; UK sample size: 130
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Interventions
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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
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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Trial website
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Publications
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1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21955538
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Contact name
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Dr
Iain
Moppett
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Address
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Nottingham University Hospitals NHS Trust
University Department of Anaesthesia
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Sponsor
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Nottingham University Hospitals NHS Trust (UK)
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Address
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City Hospital campus
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Sponsor website:
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http://www.nuh.nhs.uk/
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Date applied
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29/04/2010
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Last edited
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07/02/2012
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Date ISRCTN assigned
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29/04/2010
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