Neck of femur Optimisation Therapy-Targeted Stroke volume

ISRCTN	ISRCTN88284896
DOI	https://doi.org/10.1186/ISRCTN88284896
Protocol serial number	5165
Sponsor	Nottingham University Hospitals NHS Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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

Nottingham University Hospitals NHS Trust
University Department of Anaesthesia
Nottingham
NG5 1PB
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/08/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Nottingham University Hospitals NHS Trust

Nottingham
NG5 1PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2015		Yes	No
Protocol article	study protocol	28/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/12/2017: internal review.