Condition category
Circulatory System
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
13/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Iain Moppett

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5165

Study information

Scientific title

The use of LiDCO guided fluid administration in hip fracture surgery: a randomised interventional treatment trial

Acronym

NOTTS

Study hypothesis

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

Nottingham REC 1 approved on the 03/102008 (ref: 08AN004)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2009

Overall trial end date

01/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients listed for surgical repair of fracture neck of femur under spinal anaesthesia
2. Aged greater than 60 years, either sex

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 130; UK sample size: 130

Participant 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

Recruitment start date

01/01/2009

Recruitment end date

01/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

City Hospital campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nuh.nhs.uk/

Funders

Funder type

Charity

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21955538
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25500940

Publication citations

  1. Study protocol

    Wiles MD, Whiteley WJ, Moran CG, Moppett IK, The use of LiDCO based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: neck of femur optimisation therapy - targeted stroke volume (NOTTS): study protocol for a randomized controlled trial., Trials, 2011, 12, 213, doi: 10.1186/1745-6215-12-213.

  2. Results

    Moppett IK, Rowlands M, Mannings A, Moran CG, Wiles MD; The NOTTS Investigators, LiDCO-based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: a randomized trial and systematic review, Br J Anaesth, 2014, doi: 10.1093/bja/aeu386.

Additional files

Editorial Notes