ShockNCT03349749
The Use of LiDCOplus in Fluid Resuscitation Decision-Making
An observational study of Shock, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Unwell patients in the intensive care unit (ICU) often need supplementary fluids to be given into the bloodstream through a drip in a vein (venous cannula), however too much fluid can be harmful. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Shock
- What is being tested?
- LiDCOplus haemodynamic monitor
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2017to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients in the Intensive Care Unit (ICU) undergoing fluid resuscitation guided by fluid challenges monitored by a LiDCOplus haemodynamic monitor.
Who may be able to join
- Adult patients
- Admitted to Intensive Care Unit (ICU)
- Undergoing fluid resuscitation guided by fluid challenges
- Monitored by a LiDCOplus haemodynamic monitor attached to an arterial line
Who cannot join
- Poor arterial line trace
- Moribund state
- Patient / relative refusal
- Contra-indication to fluid bolus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Use of LiDCOplus Alter Decision-making in Fluid Prescription During Resuscitation in the Intensive Care Unit.
Unwell patients in the intensive care unit (ICU) often need supplementary fluids to be given into the bloodstream through a drip in a vein (venous cannula), however too much fluid can be harmful. It can sometimes be difficult to tell whether or not a patient will benefit from extra fluids so they are given a "fluid challenge", whereby a small volume of fluid is given quickly into the cannula and the change in their status is noted. If the patient's condition improves, this suggests that the patient is "fluid responsive" and needs more fluid.
A LiDCOplus haemodynamic monitor is a device used in the ICU to estimate the amount of blood ejected from the heart on each heartbeat using pressure readings obtained from a tube placed in one of the patient's arteries (arterial line).
The investigators aim to determine whether or not the use of this device called makes a difference to the judgement of "fluid responsiveness" when the patient is given a fluid challenge when compared to simply using measurements of pulse and blood pressure and assessing the circulation in the patient's limbs. This will allow the investigators to determine whether or not the LiDCOplus alters the decisions made by doctors and nurses about how much fluid to give their patients and hence if it is of any benefit.
- Conditions
- Shock
- Being tested
- LiDCOplus haemodynamic monitor
- Keywords
- intensive care units, resuscitation, fluid therapy, Vascular Access Devices, cardiac output, monitoring, physiologic
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiDCOplus haemodynamic monitorDevice
Patients in study group receive intravenous fluid bolus as part of standard fluid resuscitation. Fluid responsiveness (i.e. improvement in cardiac output) is estimated using both standard clinical parameters and by LiDCOplus haemodynamic monitor (with the clinician initially blinded to the latter) before a final decision about fluid responsiveness is made.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing fluid resuscitation | Adult patients in the intensive care unit (ICU) undergoing fluid resuscitation guided by the LiDCOplus haemodynamic monitor. Receives: Device: LiDCOplus haemodynamic monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness decisions changed by use of LiDCOplus
Proportion of decisions about fluid management changed by knowledge of the change in stroke volume post fluid challenge, as derived by LiDCOplus haemodynamic monitor.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start22 Mar 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James A Patterson, MBChB, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349749
- Sponsor's protocol ID
- GN16CC090
- Status last verified
- Nov 2017
- First submitted
- 25 Oct 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of LiDCOplus Alter Decision-making in Fluid Prescription During Resuscitation in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03349749
- Acronym / sponsor ID
- GN16CC090
- Conditions
- Shock
- Keywords
- intensive care units, resuscitation, fluid therapy, Vascular Access Devices, cardiac output, monitoring, physiologic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unwell patients in the intensive care unit (ICU) often need supplementary fluids to be given into the bloodstream through a drip in a vein (venous cannula), however too much fluid can be harmful. It can sometimes be difficult to tell whether or not a patient will benefit from extra fluids so they are given a "fluid challenge", whereby a small volume of fluid is given quickly into the cannula and the change in their status is noted. If the patient's condition improves, this suggests that the patient is "fluid responsive" and needs more fluid.
A LiDCOplus haemodynamic monitor is a device used in the ICU to estimate the amount of blood ejected from the heart on each heartbeat using pressure readings obtained from a tube placed in one of the patient's arteries (arterial line).
The investigators aim to determine whether or not the use of this device called makes a difference to the judgement of "fluid responsiveness" when the patient is given a fluid challenge when compared to simply using measurements of pulse and blood pressure and assessing the circulation in the patient's limbs. This will allow the investigators to determine whether or not the LiDCOplus alters the decisions made by doctors and nurses about how much fluid to give their patients and hence if it is of any benefit.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing fluid resuscitation | – | Device: LiDCOplus haemodynamic monitorAdult patients in the intensive care unit (ICU) undergoing fluid resuscitation guided by the LiDCOplus haemodynamic monitor. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients in the Intensive Care Unit (ICU) undergoing fluid resuscitation guided by fluid challenges monitored by a LiDCOplus haemodynamic monitor.
Key inclusion criteria (4 listed)
- Adult patients
- Admitted to Intensive Care Unit (ICU)
- Undergoing fluid resuscitation guided by fluid challenges
- Monitored by a LiDCOplus haemodynamic monitor attached to an arterial line
Key exclusion criteria (4 listed)
- Poor arterial line trace
- Moribund state
- Patient / relative refusal
- Contra-indication to fluid bolus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiDCOplus haemodynamic monitorPatients in study group receive intravenous fluid bolus as part of standard fluid resuscitation. Fluid responsiveness (i.e. improvement in cardiac output) is estimated using both standard clinical parameters and by LiDCOplus haemodynamic monitor (with the clinician initially blinded to the latter) before a final decision about fluid responsiveness is made. | Device | Patients undergoing fluid resuscitation |
Primary outcome
Fluid responsiveness decisions changed by use of LiDCOplus
Time frame: 10 minutes
Proportion of decisions about fluid management changed by knowledge of the change in stroke volume post fluid challenge, as derived by LiDCOplus haemodynamic monitor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Patterson, MBChB principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid responsiveness decisions changed by use of LiDCOplus (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.