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Comparison of Haemodynamic Assessment and Monitoring in Shock (CHAMS1)- a pilot study

Calibrated cardiac output monitoring versus standard care for fluid management in the shocked ICU patient: a pilot randomised control trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001373268
Enrollment
80
Registered
2018-08-15
Start date
2016-12-01
Completion date
2018-01-18
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 r

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.

Sponsors

Dr Timothy Scully
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026