Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000936325
Ethics application status
Approved
Date submitted
2/06/2017
Date registered
28/06/2017
Date last updated
15/02/2021
Date data sharing statement initially provided
15/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Lactate values as a risk stratifying tool in the Adult Emergency department for the unwell and undifferentiated patient

Scientific title
The usefulness and validity of using lactate clearance and serial lactate measurements in the Emergency Department as a risk stratifying tool for the unwell and undifferentiated adult patient
Secondary ID [1] 292047 0
Nil known
Universal Trial Number (UTN)
U1111-1197-0257
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unwell and Undifferentiated patient 303479 0
Shortness of breath 303480 0
Chest pain 303481 0
Syncope 303482 0
Sepsis 303483 0
Condition category
Condition code
Public Health 302897 302897 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will be observing lactate clearance in the emergency department patient that are undifferentiated and unwell adult patients and if this is a useful tool in identifying the deteriorating patient early and those that need to be admitted into hospital for care. These patients will have their capillary/venous/arterial lactate recorded by a point of care device from Nova Biomedical measured at 1 hour and 3 hours of stay. Their readings and clearance and range will be looked at and their patient disposition ie discharge point to home, hospital, critical care unit and deaths. Their outcome will be observed for 72 hours post leaving the Emergency Department.

These lactate measurements will be taken from different groups of patients in the emergency department at different times so that it allows for staff to focus on one group at a time eg sepsis patients, patients with shortness of breath.
Intervention code [1] 298210 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302287 0
Mortality (death)
Timepoint [1] 302287 0
72 hours post ED discharge
Primary outcome [2] 302288 0
Discharge location ie home , rehabilitation or still as inpatient- will be determined by medical record review and phone call at 72 hours post discharge from hospital (as inpatient or from Emergency Department)
Timepoint [2] 302288 0
The time they leave emergency and at 72 hours post leaving the emergency department
Primary outcome [3] 302289 0
The range of lactate readings for our focus population in the emergency department using the nova lactate meter.
Timepoint [3] 302289 0
1 hour of stay and 3 hours of stay in the emergency department
Secondary outcome [1] 335380 0
Triage number and if that was changed to a higher category number as a result of using the Statstrip lactate meter (High reading) using our medical record system in the emergency department Firstnet
Timepoint [1] 335380 0
at the time of entry at study and whilst in the emergency department
Secondary outcome [2] 335381 0
if the location of patient changed in the emergency department to a more acute setting ie acute care to resuscitation bay by using the medical record whilst they are in emergency (Firstnet)
Timepoint [2] 335381 0
time in ED
Secondary outcome [3] 335385 0
Cost of running the StatStrip point of care lactate meter vs using the venous blood gas machine (Roche BL800) theoretically if used instead. This will be calculated using excel spreadsheet per patient and the costs for the department.
Timepoint [3] 335385 0
Times used in the emergency department for each patient

Eligibility
Key inclusion criteria
- Person greater than or equal to 18 years of age
- Triaged for assessment in adult acute assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion of persons with the following comorbidities/presentation:
1. Seizure
2. Severe hepatic failure
3. Patients that did not stay for their treatment in the department
4. Biguanide therapy (phenformin, metformin)
5. Patients unable to give consent eg low GCS, dementia

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be recorded using statistical database software such as SPSS to analyse and store data. We will then analyse the data to look for cut off points from a receiver operator characteristic curve to compare deterioration of a patient in the department or first 72 hours, disposition of a patient is discharge from ED location and mortality.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2018
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8208 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 16267 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 296580 0
Hospital
Name [1] 296580 0
Royal North Shore Hospital Emergency Department
Country [1] 296580 0
Australia
Funding source category [2] 296840 0
Commercial sector/Industry
Name [2] 296840 0
Nova Biomedical
Country [2] 296840 0
United States of America
Primary sponsor type
Individual
Name
Louisa Ng
Address
Royal North Shore Hospital Emergency Department
Reserve Road, St Leonards 2065, NSW
Country
Australia
Secondary sponsor category [1] 295535 0
Individual
Name [1] 295535 0
Mark Gillett
Address [1] 295535 0
Royal North Shore Hospital Emergency Department
Reserve Road, St Leonards 2065, NSW
Country [1] 295535 0
Australia
Other collaborator category [1] 279593 0
Commercial sector/Industry
Name [1] 279593 0
Nova Biomedical
Address [1] 279593 0
Nova Biomedical
200 Prospect Street
Waltham, MA 02454-9141 U.S.A.
Country [1] 279593 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297804 0
NORTHERN SYDNEY LOCAL HEALTH DISTRICT KOLLING RESEARCH OFFICE
Ethics committee address [1] 297804 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, St Leonards, NSW, 2065
Ethics committee country [1] 297804 0
Australia
Date submitted for ethics approval [1] 297804 0
Approval date [1] 297804 0
22/12/2016
Ethics approval number [1] 297804 0

Summary
Brief summary
Research Question
Can measurements of lactate clearance with a point of care lactate measuring device (StatStripAccutrend) assist in the management and early identification of patients at higher risk of deterioration in the emergency department?
Rationale for Current Study
In the emergency department, the undifferentiated patient presents a diagnostic and time management challenge. Lactate is used as a surrogate marker for global hypoperfusion in sepsis, trauma and patients with surgical abdomens, but there are also other areas of developing interest where lactate measurements could be used to assist in fast tracking decisions and risk stratifying patients to decide their disposition.
Primary Objective
1. To measure serial lactate measurements in the ED within the first hour of presentation and at 3 hours of stay to monitor and predict deterioration in the department or the hospital in the first 72 hours?
STUDY DESIGN
This study is a prospective longitudinal study where data will be collected over a year. The data will be collected with written or and verbal consent, and fact sheet given to the participant about the study. Verbal and written consent will be obtained at the first reading and second readings taken to make sure that participants are happy to continue with the study. Patients can withdraw at any time in the study. Exclusion criteria of patients will include those that are <18 years old, severe hepatic failure, presentation of known seizure disorders and those triaged to other areas apart from the adult acute area or self discharged from the department before completion of treatment, if they don’t have a serial measurement of their lactate at 3 hours. The lactate measurements will be recorded at a time within one hour of presentation and the second reading at 3 hours of presentation electronically on their medical records. The data will then be extracted and de-identified for this research project and determined if the participant is to be excluded or included in the study. . This study to reach the sample size of 1000 participants would approximately go over the course of 6 months to a year.
Trial website
Trial related presentations / publications
Public notes
Nova Biomedical will be supplying equipment for no fee and will not influence the study nor access to raw data - only final data and write up and interim reports

Contacts
Principal investigator
Name 75142 0
Dr Louisa Ng
Address 75142 0
Royal North Shore Hospital
Emergency Department
Reserve Road
St Leonards, New South Wales
2065
Country 75142 0
Australia
Phone 75142 0
+61425247862
Fax 75142 0
Email 75142 0
rnshedlactate@gmail.com
Contact person for public queries
Name 75143 0
Mark Gillett
Address 75143 0
Royal North Shore Hospital
Emergency Department
Reserve Road
St Leonards, New South Wales
2065
Country 75143 0
Australia
Phone 75143 0
+61294632222
Fax 75143 0
Email 75143 0
Mark.Gillett@health.nsw.gov.au
Contact person for scientific queries
Name 75144 0
Mark Gillett
Address 75144 0
Royal North Shore Hospital
Emergency Department
Reserve Road
St Leonards, New South Wales
2065
Country 75144 0
Australia
Phone 75144 0
+61294632222
Fax 75144 0
Email 75144 0
Mark.Gillett@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For reasons of privacy and for data to remained unskewed from sponsoring parties andfrom general public


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.