Data

ECHONOF III trial - participants with isolated, primary and non metastatic NOF

The University of Melbourne

Dataset description

The ECHONOF III trial aims to recruit patients presenting with isolated, primary, non-metastatic fractured neck of femur, where surgery is expected within 48 hours after hospital admission. Depend on randomisation outcome, 50% of the trial participants will receive trial intervention. The intervention is not a stand-alone product per se, but rather an ultrasound examination of the heart. In addition to clinical evaluation, participants randomised to the focused cardiac ultrasound group will receive a preoperative focused cardiac ultrasound performed prior to surgery, following The University of Melbourne iHeartScan protocol. The control group will consist of current standard of care practice which does not involve routine use of preoperative focused cardiac ultrasound. The study dataset may also include a set of QoL surveys, such as PostopQRS survey, clinical frailty scale, ED-5D-5L and Lawton Brody IADL scale. Please note that the study dataset may only be available once the ECHONOF III trial is completed and concluded. Assessing and utilising the ECHONOF III dataset for research purposes may require additional ethical approval.
Click to explore relationships graph

Subjects

Surgery |

Source Study

Purpose

Diagnosis

Phase

Not Applicable

Funding

Government body,Department of Health and Aged Care (Medical research future fund)

Scientific enquiries

Prof Colin Royse

Brief Summary

ECHONOF III is a parallel group, pragmatic randomised controlled multi-centre trial, in which patients presenting with hip fracture are randomised to receive or not receive preoperative focused transthoracic echocardiography (TTE) before surgery. The trial aims to assess whether adding a focused TTE will lead to a reduced composite outcome of at least one of: all-cause mortality, cardiac failure, myocardial injury in noncardiac surgery, acute kidney injury or hospital readmission at 30 days post ....
Read more

Key Inclusion Criteria

Patients presenting with isolated, primary, non-metastatic fractured neck of femur surgery is expected within 48 hours after hospital admission

Key Exclusion Criteria

Prior hip surgery on the affected side Likely metastatic cancer Survival is unlikely in the 24 hours from admission Having an echocardiography done in the last 30 days

Can healthy volunteers participate?

No

 

Population

Sample Size    2000

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Hip fracture

Condition code    Injuries and Accidents

Intervention

Intervention code Diagnosis / Prognosis

The intervention is a Focused Transthoracic Echocardiography (TTE) in addition to the standard pre-operative evaluation. It is performed before surgery by a doctor (anaesthetist, internal medicine physician, surgeon or cardiologist) proficient in point-of-care ultrasound and trained in the University of Melbourne iHeartScan protocol. The focused TTE is performed at the bedside of the patient and takes up to 15 minutes to be completed. The test involves a brief assessment of the left and right ve ....
Read more

Comparison

Control group Active

A standard pre-operative assessment performed by the anaesthetist, which does not include focused transthoracic echocardiography. This assessment takes around 10 to 15 minutes and involves recollection of the medical history, vital signs (blood pressure, heart rate, respiratory rate and oxygen saturation) and physical examination.

Outcomes

Outcome: A composite outcome of the incidence of all-cause mortality, hospital readmission, acute kidney injury, decompensated cardiac failure and myocardial injury in non-cardiac surgery (MINS). Data will be collected from patient medical records. Measurement of the levels of troponin for the diagnosis of MINS is outside the standard of care and is considered "an investigative test" that will be organised by the research team and collected at baseline, day 1 and day 2 post sur ....
Read more

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Demographic data and primary outcome.

When will data be available?

After publication. No end date.

Available to whom?

Investigators with a research project proposal. It will require ethics approval to share.

Available for what types of analyses?

Systematic review with meta-analysis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au