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Trial registered on ANZCTR


Registration number
ACTRN12618001373268
Ethics application status
Approved
Date submitted
3/08/2018
Date registered
15/08/2018
Date last updated
15/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Haemodynamic Assessment and Monitoring in Shock (CHAMS1)- a pilot study
Scientific title
Calibrated cardiac output monitoring versus standard care for fluid management in the shocked ICU patient: a pilot randomised control trial
Secondary ID [1] 295736 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock 309134 0
Sepsis 309135 0
Condition category
Condition code
Cardiovascular 308014 308014 0 0
Other cardiovascular diseases
Emergency medicine 308070 308070 0 0
Other emergency care
Infection 308071 308071 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will have 72 hours of monitoring following randomisation with an EV1000/VolumeView monitoring device. An EV1000/VolumeView system is a haemodynamic monitoring device which utlises transpulmonary thermodilution method to provide calibrated haemodynamic parameters to guide fluid resuscitation. To provide transpulmonary thermodilution, an internal jugular or subclavian central line and a femoral arterial line must be inserted to the study participant. ICU clinicians will be responsible for the placement of an internal jugular or subclavian central line and a femoral arterial line to fit the EV1000/VolumeView device. An EV1000/VolumeView provides constant haemodynamic parameters which require calibration by transpulmonary thermodilution every 4 hours. Nursing staff were responsible for calibration of the devices every 4 hours during the intervention period. Once the EV1000/VolumeView was established, there was no further active interventions for the interventional group or the control group.
Intervention code [1] 312061 0
Treatment: Devices
Comparator / control treatment
In the control group, the treating ICU team could use any method of assessing fluid status/responsiveness commonly utilized in our ICU. This includes clinical examination, trends in blood pressure/lactate/urine output and transthoracic echocardiogram.
Control group
Active

Outcomes
Primary outcome [1] 307006 0
Primary outcome of the study was total intravenous fluid use at 72 hours post randomisation. Intravenous fluid use is recorded on both fluid infusion charts and a total daily fluid balance chart is kept on our online medical records system. Cross checking the infusion charts and fluid balance chart allows assessment of total IV fluid use.
Timepoint [1] 307006 0
72 hours post-enrolment into the study
Secondary outcome [1] 350333 0
A secondary outcome was assessment of rationale for initiating fluid boluses. A study specific questionnaire was at patient's nursing station and was to be filled in at the time of each fluid bolus. The most senior clinician responsible for initiating a fluid bolus was asked to record the volume of bolus, type of fluid used, which parameters (eg. Heart rate, blood pressure, rising lactate, EV1000/VolumeView output) they used to decide a fluid bolus was necessary and which parameters they assessed following the fluid bolus to determine if the fluid bolus acheived their desired result.
Timepoint [1] 350333 0
The questionnaire was to be completed any time a fluid bolus was given from enrollment to the intervention endpoint at 72 hours. If multiple boluses given, multiple questionnaires were completed for each study participant.
Secondary outcome [2] 350570 0
Feasibility of trial; assessed by whether the sample size target is achieved and on number of patient fluid bolus questionnaires completed by the treating clinician
Timepoint [2] 350570 0
To be evaluated at end of trial

Eligibility
Key inclusion criteria
adult patients (18 years or older) admitted with shock defined as ongoing hypotension, despite fluid resuscitation, requiring vasopressors to maintain mean arterial blood pressure (MAP) greater than or equal to 65 mm Hg +/- and a serum lactate greater than or equal to 2 mmol/L.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients in hypovolemic/haemorrhagic shock or atrial fibrillation (AF), pre-existing need for dialysis, pregnancy and patients who were unlikely to remain in the ICU for at least 72 hours. Additionally, patients were excluded if advanced haemodynamic monitoring was consider essential by the treating clinician.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation was performed via an independent statistician with block size of 4 and 1:1 allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size estimation using data from Pittard (2017) with an effect size of 300mls and standard deviation of 2000mls, determined that 697 patients would be required for a full study. Given this was a pilot trial to determine feasibility, we aimed to recruit at least 10% of this calculated number, as per pilot sample size guidelines established by Cocks and Torgerson (2013).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11589 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 23632 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 300328 0
Hospital
Name [1] 300328 0
Nepean Hospital
Address [1] 300328 0
Derby St, Kingswood NSW 2747
Country [1] 300328 0
Australia
Primary sponsor type
Individual
Name
Dr Timothy Scully
Address
Nepean Hospital
Derby St, Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 299764 0
None
Name [1] 299764 0
Address [1] 299764 0
Country [1] 299764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301139 0
Nepean Blue Mountains Local Health District HREC [EC00151]
Ethics committee address [1] 301139 0
Nepean Blue Mountains Local Health District Nepean Hospital
PO Box 63
Penrith NSW 2751
Ethics committee country [1] 301139 0
Australia
Date submitted for ethics approval [1] 301139 0
16/09/2016
Approval date [1] 301139 0
22/09/2016
Ethics approval number [1] 301139 0
Study 16/54 – HREC/16/NEPEAN/89

Summary
Brief summary
There is minimal evidence that the use of cardiac output monitor devices leads to an overall change in IV fluid use. We sought to investigate the feasibility of performing a randomised controlled study using calibrated cardiac output monitoring devices in shocked ICU patients and whether the use of these devices led to a difference in total volume of IV fluid administered.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85986 0
Dr Timothy Scully
Address 85986 0
Nepean Hospital
Derby Street, Kingswood New South Wales 2747
Country 85986 0
Australia
Phone 85986 0
+61 401 397 550
Fax 85986 0
Email 85986 0
tgraemescully@gmail.com
Contact person for public queries
Name 85987 0
Dr Timothy Scully
Address 85987 0
Nepean Hospital
Derby Street, Kingswood New South Wales 2747
Country 85987 0
Australia
Phone 85987 0
+61 401 397 550
Fax 85987 0
Email 85987 0
tgraemescully@gmail.com
Contact person for scientific queries
Name 85988 0
Dr Sam Orde
Address 85988 0
Nepean Hospital
Derby Street, Kingswood New South Wales 2747
Country 85988 0
Australia
Phone 85988 0
+61 404648794
Fax 85988 0
Email 85988 0
samorde@hotmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary