ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shock

Sepsis

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Emergency medicine

Other emergency care

Infection

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]

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]

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]

72 hours post-enrolment into the study

Secondary outcome [1]

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]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/12/2016

Date of last participant enrolment

Anticipated

Actual

18/01/2018

Date of last data collection

Anticipated

Actual

24/01/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Nepean Hospital

Address [1]

Derby St, Kingswood NSW 2747

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Timothy Scully

Address

Nepean Hospital
Derby St, Kingswood NSW 2747

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Nepean Blue Mountains Local Health District HREC [EC00151]

Ethics committee address [1]

Nepean Blue Mountains Local Health District Nepean Hospital 
PO Box 63
Penrith NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/09/2016

Approval date [1]

22/09/2016

Ethics approval number [1]

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

Dr Timothy Scully

Address

Nepean Hospital
Derby Street, Kingswood New South Wales 2747

Country

Australia

Phone

+61 401 397 550

Fax

tgraemescully@gmail.com

Contact person for public queries

Name

Timothy Scully

Address

Nepean Hospital
Derby Street, Kingswood New South Wales 2747

Country

Australia

Phone

+61 401 397 550

Fax

tgraemescully@gmail.com

Contact person for scientific queries

Name

Sam Orde

Address

Nepean Hospital
Derby Street, Kingswood New South Wales 2747

Country

Australia

Phone

+61 404648794

Fax

samorde@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		5. Scully TG, Grealy R, McLean AS et al. (2019). C... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Calibrated cardiac output monitoring versus standard care for fluid management in the shocked ICU patient: A pilot randomised controlled trial.	2019	https://dx.doi.org/10.1186/s40560-018-0356-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically