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Hip FracturesClearNOFNCT02382185

Non Invasive Cardiac Output Monitoring to Guide Goal Directed Fluid Therapy in High Risk Patients Undergoing Urgent Surgical Repair of Proximal Femoral Fractures

A study testing Fluid optimisation, Optimisation of blood pressure and Application of clearsight monitor in people with Hip Fractures, run by York Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Improving or maximising cardiac output in the perioperative setting through the use of goal directed fluid therapy has been shown to reduce complications and length of hospital stay in patients undergoing major abdominal surgery. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Hip Fractures
What is being tested?
Fluid optimisation, Optimisation of blood pressure and Application of clearsight monitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesUnited Kingdom
Study dates
Jan 2015to 28 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients due to undergo urgent or emergency repair of a proximal femoral fracture who have a Nottingham hip fracture score (NHFS) ≥ 5 i.e. patients who are regarded as 'high risk'.

Who cannot join

  • Age < 50 years. Patients scoring 5 on the American Society of Anesthesiologists (ASA) physical status classification Multiple injuries requiring operative management

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Harrogate Hospital

    Harrogate, Yorkshire

  • York Teaching Hospitals NHS Foundation Trust

    York, North Yorkshire, YO318HE

Other trials in United Kingdom

About this study

Improving or maximising cardiac output in the perioperative setting through the use of goal directed fluid therapy has been shown to reduce complications and length of hospital stay in patients undergoing major abdominal surgery. The evidence for patients having surgery to repair a fractured neck of femur is less robust but many of these latter patients are elderly and often at high risk of complications.

Patients undergoing surgery (including surgery for hip fracture) under spinal anaesthesia have not had access to goal directed fluid therapy because of the invasive nature of the existing monitoring technology such as oesophageal doppler. The availability of a non invasive cardiac monitoring device, the Clearsight™, now makes goal directed fluid therapy a possibility for this group of patients.

Read more

This is a randomised controlled, observer blinded trial to assess the effects of goal directed fluid therapy in high-risk patients undergoing surgical repair of proximal femoral fractures.

The aim of the trial is to test the hypothesis that maximising circulating volume intra-operatively with balanced crystalloid reduces post-operative morbidity in high-risk patients undergoing urgent surgical repair of proximal femoral fractures.

Read the detailed description

The management of fractured neck of femur in the elderly population is of clinical and political interest in the United Kingdom at present, with a current national audit in progress to look at anaesthetic management and clinical outcomes. It is estimated that the number of patients that sustain a hip fracture will reach 100,000 cases per annum by 2033 with a cost to the NHS of some £ 2.7 billion. Outcomes for this group remain poor with a mortality of 8% at 1 month, increasing to 20-33% at 1 year4. Complication rates for this group also remain significant with between 20 and 60% of patients having significant postoperative complications. These complications are not only associated with increased length of stay and healthcare costs, but also reduced long-term survival.

Improving or maximising cardiac output in the perioperative setting either through the use of intravenous fluids, or in combination with inotropes has been shown to reduce complication rates following surgery in a variety of settings including those with fractured neck of femurs. A recent meta analysis of optimisation trials has shown that for every 100 patients in whom the intervention is provided, patients will avoid a complication, and length of stay will be reduced by 1 day. Importantly the intervention is also associated with no harm. In 1997 by using the oesophageal Doppler to guide fluid therapy in an attempt to maximise cardiac output, Sinclair managed to reduce the time patients who were operated on for a fractured neck of femur were deemed fit for medical discharge from 15 to 10 days (P<0.05). Stroke volume was significantly increased in the protocol group, and although postoperative complication rates were not reported in this trial, it is inferred that they were reduced. A similar trial comparing conventional fluid therapy versus therapy guided by either central venous pressure measurements or oesophageal Doppler showed a similar reduction in time to being medically fit for discharge. This trial did report morbidity, which showed a non-significant trend to improvement in subjects who received oesophageal Doppler monitoring.

One of the main limitations of these trials are the relatively small numbers, with just 20 per group in the Sinclair trial and 30 per groups in the Venn trials, yet even with small numbers an improvement in outcome was seen. A larger trial has recently been completed using a more invasive calibrated measure of cardiac output, targeting a somewhat aggressive oxygen delivery of > 600ml/min/m2 using inotropic support in elderly fractured neck of femur patients. Few patients actually achieved this goal, however there was again a non-significant reduction in complications (RR 0.79, 95% CI 0.54-1.16) however the trial was underpowered due to issues with recruitment. The trial recruited 149 patients in total and to date is the largest study to examine this population despite the impact that this population has on the health services both within the NHS and worldwide. In addition all of the trials described included in their recruitment a broad group of patients some of whom could be considered to be at low risk of post operative complications.

Within this group of elderly patients a high-risk group exist. The Nottingham hip fracture score (NHFS) is a validated scoring system that predicts patients at increased risk of both 30 day and 1-year mortality. A NHFS ≥ 5 was associated with a mortality of 13.7% vs. 3.5% at 30 days (P<0.001) and 45.5% vs. 15.9% at 1 year (P<0.001). It is assumed that this high-risk group with an increased mortality rate also have an increased complication rate, and hence any effective intervention would have a greater impact on outcomes.

An increasing number of operations to repair fractured necks of femur are being performed awake under spinal anaesthesia. Technology such as oesophageal Doppler is not suitable as it cannot easily be tolerated when awake, and arterial based pulse waveform analysis requires an invasive procedure to be performed. Hence many patients do not receive goal directed therapy even though it may be of clinical benefit. A recent economic analysis has also suggested that goal directed therapy in this group is not only cost effective but also associated with cost savings.

The Clearsight™ non invasive cardiac output device measures blood pressure using the volume clamp method developed by the Czech physiologist Jan Penaz. Using a simple non-invasive finger cuff, the volume of an artery is kept clamped at a constant diameter. Changes in diameter are measured by a photo-plethysmograph within the finger cuff, and a servo controller applies counter pressure to keep the diameter of the artery constant. This allows the measurement of beat to beat blood pressure and hence cardiac output can also be calculated. The simple and non invasive nature of this device makes it suitable to use in patients undergoing repair of fractured neck of femur regardless of the type of anaesthetic. It requires no calibration, and would make goal directed therapy accessible to this group. The Clearsight has been shown to be a valid measure of cardiac output.

Conditions
Hip Fractures
Being tested
Fluid optimisation, Optimisation of blood pressure, Application of clearsight monitor
Keywords
Cardiac output
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluid optimisationOther

    The intervention will consist of optimising stroke volume with 250ml of Hartmanns solution

  • Optimisation of blood pressureDrug

    Phenylephrine infusion will be used to target a mean arterial blood pressure to within 30% of baseline (preoperative) value

  • Application of clearsight monitorDevice

    The clear sight monitor will be applied to measure stroke volume.

Study groups in NCT02382185
Study groupRoleWhat they receive
Usual careExperimentalNo intervention apart from application of clearsight monitor. Prior to induction of anaesthesia the control group will have a Clearsight cardiac monitor probe placed on a suitable finger and baseline haemodynamic measurements will be taken. All fluid management and administration of vasopressor therapy will be at the discretion of the anaesthetist as per the current practice at the host institution. Data on stroke volume, heart rate, blood pressure, cardiac output, oxygen saturations, will be recorded at baseline and then every 5 minutes.
Receives: Device: Application of clearsight monitor
Fluid optimisationExperimentalApplication of clearsight monitor, optimisation of blood pressure and fluid optimisation. A Clearsight cardiac probe is attached and after induction of anaesthesia stroke volume is optimised using 250ml boluses of Hartmann's solution. The SV measurement prior to the final fluid bolus will be the optimal SV. Mean arterial blood pressure will be maintained within 30% of baseline values using a phenylephrine infusion.Data on haemodynamics will be recorded at baseline and then every 5 minutes, as well as before and after a fluid bolus. Haemoglobin will be maintained at>10g/dL with blood transfusion as required.
Receives: Other: Fluid optimisation; Drug: Optimisation of blood pressure; Device: Application of clearsight monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite basket of complication

    The number of patients who develop one or more in hospital post operative complications as defined by Copeland (POSSUM) and modified for this patient group

    Measured: In hospital participants are expected to have a median hospital length of stay of 18 days

Secondary outcomes (11)
  1. Incidence of major and minor complications

    Incidence of major and minor complications

    Measured: in hospital -Participants are expected to have a median hospital length of stay of 18 days

  2. Morbidity at day 3, 5, 10 measured by Post operative morbidity survey

    Morbidity at day 3, 5, 10 measured by Post operative morbidity survey

    Measured: 10 days

  3. Length of stay in hospital after surgery.

    Length of stay in hospital after surgery.

    Measured: In hospital- participants are expected to have a median hospital length of stay of 18 days

  4. time to drinking

    time to drinking

    Measured: in hospital - participants are expected to have a median hospital length of stay of 18 days

  5. time to eating

    time to eating

    Measured: in hospital - participants are expected to have a median hospital length of stay of 18 days

  6. time to mobilisation

    time to mobilisation

    Measured: in hospital - participants are expected to have a median hospital length of stay of 18 days

  7. Change ineri-operative haemodynamic variables - heart rate.

    Change ineri-operative haemodynamic variables - heart rate.

    Measured: perioperative - from start of surgery to end

  8. Change in peri-operative haemodynamic variables - blood pressure

    Change in peri-operative haemodynamic variables - blood pressure

    Measured: perioperative - from start of surgery to end

  9. Change in peri-operative haemodynamic variables - stroke volume

    Change in peri-operative haemodynamic variables - stroke volume

    Measured: perioperative - from start of surgery to end

  10. Incidence of perioperative hypotension.

    Incidence of perioperative hypotension.

    Measured: perioperative

  11. Total dose of administered vasopressor.

    Total dose of administered vasopressor.

    Measured: perioperative - from start of surgery to end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2015 (estimated)
  2. Study startJan 2015
  3. Primary completion28 Sep 2017
  4. Study completion28 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02382185
Sponsor's protocol ID
YOR-A02333
Acronym
ClearNOF
Status last verified
Jun 2018
First submitted
2 Feb 2015
Last updated
2 Jul 2018
Results posted
No
Data monitoring committee
No

Publications

  • Davies SJ, Yates DR, Wilson RJT, Murphy Z, Gibson A, Allgar V, Collyer T. A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185). Perioper Med (Lond). 2019 Aug 8;8:8. doi: 10.1186/s13741-019-0119-x. eCollection 2019.

    PubMed 31406569

Questions about this trial

What is this clinical trial studying?

A study testing Fluid optimisation, Optimisation of blood pressure and Application of clearsight monitor in people with Hip Fractures, run by York Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite basket of complication (time frame: In hospital participants are expected to have a median hospital length of stay of 18 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02382185, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.

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