Cardiac Output, LowNCT03058653
Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
A study testing Small fluid boluses of 50 ml and LIDCORapid Monitor in people with Cardiac Output, Low and Cardiac Output, High, run by The Royal Wolverhampton Hospitals NHS Trust.
Trial summary
On the Intensive Care Unit doctors give a lot of fluid to patients in order to improve their blood pressure, amount of urine made or to let doctors stop drugs that are needed to keep blood pressure up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low, Cardiac Output, High
- What is being tested?
- Small fluid boluses of 50 ml and LIDCORapid Monitor
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters
Who cannot join
- Age under 18
- severe haemodynamic instability
- persistent arrhythmia (including atrial fibrillation)
- pregnant patients
- palliative care only patients
About this study
On the Intensive Care Unit doctors give a lot of fluid to patients in order to improve their blood pressure, amount of urine made or to let doctors stop drugs that are needed to keep blood pressure up. Doctors normally give patients 500ml of fluid over 25 minutes as standard, however it is very difficult to know if giving those fluids and how much fluid will help (it does in some but not others). If a person gets too much fluid this can also cause problems such as fluid in lungs, poor kidney function, or swelling in the limbs.
The LidCo Rapid monitor lets the Intensive Care Unit (ICU) team know the amount of blood the heart pushes out with each beat (Stroke volume). It works by following the tracing off the arterial line (Blood pressure monitor) that has been inserted as part of the standard care of a patient on the ICU. It does not need any other invasive procedures or drug administration to work.
This study is using this monitor to see if it can identify a method of improving the administration of intravenous fluids on the Intensive Care Unit. The study is looking to see if it can identify whether giving a small amount of fluid first identifies people who will benefit from more fluid and those that won't.
Read the detailed description
Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters will be approached. Reasons for fluid administration include evidence of inadequate tissue perfusion such as raised blood lactate or poor urine output, hypotension or attempts to wean vasopressor dose.
Patients will be identified as suitable for inclusion by the Consultant Responsible for the Intensive Care Unit on each day. As fluid responsiveness is a transient phenomenon which disappears after significant fluid resuscitation it is proposed that patients will be immediately entered into the study so that the study contains a mix of fluid responsive and non-responsive patients in order to get the time critical data required which may be lost if there is a significant delay before study entry. Informed consent will be sought from the patient, or if they are incapacitated by critical illness, their relative will be approached for assent as soon as possible and within 48 hours of study enrollment. This is in line with recommendations for Research involving emergency treatment.
The LiDCOrapid machine will be connected in the same manner as the LiDCOplus machine, currently in use on ICU, in order to obtain the stroke volume measurement. A smartcard is inserted and the patient details entered. Monitoring will continue until fluids are clinically indicated. Patients will be given fluid boluses via either peripheral or central venous catheters.
The following data will be collected for each patient:
Age, Gender, Height, Weight, diagnosis requiring ICU admission, location of venous and arterial catheters, APACHE II scores, Cumulative fluid balance at time of bolus administration, Ventilation status (self-ventilating, non-invasive ventilation, invasive ventilation and mode if appropriate), tidal volume if measured, drugs being infused (sedatives, inotropes, vasoactive drugs, diuretics, muscle relaxants, etc), presence of renal replacement therapy.
Fluid administration protocol:
Patients will be monitored just prior to infusion for hemodynamic stability, Standard practice is to administer a bolus of 500ml given via an infusion pump at a rate of 1200mL/hour (25min).
For study patients the first 250ml will be given in 50ml boluses using a 50ml syringe. Each bolus will be given over approximately 1 minute and the study measurements will be recorded followed by a wait for response of 1 minute. This will be repeated for each subsequent bolus until 250ml has been given (i.e. 5 boluses). The remaining 250ml will be given via the standard infusion pump method at a rate of 1000ml/hour which will complete in 15 minutes. In total, the 500ml will be given over 25 minutes.
At the end of each bolus Stroke volume, cardiac output, heart rate, blood pressure will be determined.
Up to 2 sets of data per patient per day will be collected. The majority of patients routinely stay in the ICU for 2 days, while in a smaller group, for much longer. A maximum of 4 data sets will be collected per patient. The fluid boluses will be administered at the discretion of the treating physician who believes that they will improve the clinical condition of the patient. The study team will have no influence on the timing of these.
- Conditions
- Cardiac Output, Low, Cardiac Output, High
- Being tested
- Small fluid boluses of 50 ml, LIDCORapid Monitor
- Medical subject headings
- Cardiac Output, Low, Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small fluid boluses of 50 mlProcedure or surgery
Participants will receive small 50ml boluses of fluid up to 250ml in total. The remainder will be given as infusion pump method at a rate of 1000ml/hour which will complete in 15 minutes. In total, the 500ml will be given over 25 minutes.
LIDCORapid MonitorDevice
Addition of the LIDCORapid Monitor to measure stroke volume
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Experimental | Small fluid boluses - The first 250ml of fluid will be given in 50ml boluses using a 50ml syringe Receives: Procedure: Small fluid boluses of 50 ml; Device: LIDCORapid Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume
measurement of stroke volume after each bolus of fluid has been given
Measured: 1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days
Cardiac out-put
If Cardiac output increased by 15% then the patient is defined as a "fluid responder" and should receive more fluid. If there is not a 15% increase, then the patient will have no benefit from further fluid loading.
Measured: 1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew MacDuff, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058653
- Sponsor's protocol ID
- 2017CRI89
- Status last verified
- May 2022
- First submitted
- 7 Feb 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT03058653
- Acronym / sponsor ID
- 2017CRI89
- Conditions
- Cardiac Output, Low, Cardiac Output, High
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 23 Feb 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.
On the Intensive Care Unit doctors give a lot of fluid to patients in order to improve their blood pressure, amount of urine made or to let doctors stop drugs that are needed to keep blood pressure up. Doctors normally give patients 500ml of fluid over 25 minutes as standard, however it is very difficult to know if giving those fluids and how much fluid will help (it does in some but not others). If a person gets too much fluid this can also cause problems such as fluid in lungs, poor kidney function, or swelling in the limbs.
The LidCo Rapid monitor lets the Intensive Care Unit (ICU) team know the amount of blood the heart pushes out with each beat (Stroke volume). It works by following the tracing off the arterial line (Blood pressure monitor) that has been inserted as part of the standard care of a patient on the ICU. It does not need any other invasive procedures or drug administration to work.
This study is using this monitor to see if it can identify a method of improving the administration of intravenous fluids on the Intensive Care Unit. The study is looking to see if it can identify whether giving a small amount of fluid first identifies people who will benefit from more fluid and those that won't.
Detailed description
Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters will be approached. Reasons for fluid administration include evidence of inadequate tissue perfusion such as raised blood lactate or poor urine output, hypotension or attempts to wean vasopressor dose.
Patients will be identified as suitable for inclusion by the Consultant Responsible for the Intensive Care Unit on each day. As fluid responsiveness is a transient phenomenon which disappears after significant fluid resuscitation it is proposed that patients will be immediately entered into the study so that the study contains a mix of fluid responsive and non-responsive patients in order to get the time critical data required which may be lost if there is a significant delay before study entry. Informed consent will be sought from the patient, or if they are incapacitated by critical illness, their relative will be approached for assent as soon as possible and within 48 hours of study enrollment. This is in line with recommendations for Research involving emergency treatment.
The LiDCOrapid machine will be connected in the same manner as the LiDCOplus machine, currently in use on ICU, in order to obtain the stroke volume measurement. A smartcard is inserted and the patient details entered. Monitoring will continue until fluids are clinically indicated. Patients will be given fluid boluses via either peripheral or central venous catheters.
The following data will be collected for each patient:
Age, Gender, Height, Weight, diagnosis requiring ICU admission, location of venous and arterial catheters, APACHE II scores, Cumulative fluid balance at time of bolus administration, Ventilation status (self-ventilating, non-invasive ventilation, invasive ventilation and mode if appropriate), tidal volume if measured, drugs being infused (sedatives, inotropes, vasoactive drugs, diuretics, muscle relaxants, etc), presence of renal replacement therapy.
Fluid administration protocol:
Patients will be monitored just prior to infusion for hemodynamic stability, Standard practice is to administer a bolus of 500ml given via an infusion pump at a rate of 1200mL/hour (25min).
For study patients the first 250ml will be given in 50ml boluses using a 50ml syringe. Each bolus will be given over approximately 1 minute and the study measurements will be recorded followed by a wait for response of 1 minute. This will be repeated for each subsequent bolus until 250ml has been given (i.e. 5 boluses). The remaining 250ml will be given via the standard infusion pump method at a rate of 1000ml/hour which will complete in 15 minutes. In total, the 500ml will be given over 25 minutes.
At the end of each bolus Stroke volume, cardiac output, heart rate, blood pressure will be determined.
Up to 2 sets of data per patient per day will be collected. The majority of patients routinely stay in the ICU for 2 days, while in a smaller group, for much longer. A maximum of 4 data sets will be collected per patient. The fluid boluses will be administered at the discretion of the treating physician who believes that they will improve the clinical condition of the patient. The study team will have no influence on the timing of these.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | Experimental | Procedure: Small fluid boluses of 50 ml, Device: LIDCORapid MonitorSmall fluid boluses - The first 250ml of fluid will be given in 50ml boluses using a 50ml syringe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters
Key exclusion criteria (5 listed)
- Age under 18
- severe haemodynamic instability
- persistent arrhythmia (including atrial fibrillation)
- pregnant patients
- palliative care only patients
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 |
|---|---|---|
| Small fluid boluses of 50 mlParticipants will receive small 50ml boluses of fluid up to 250ml in total. The remainder will be given as infusion pump method at a rate of 1000ml/hour which will complete in 15 minutes. In total, the 500ml will be given over 25 minutes. | Procedure or surgery | Study patients |
| LIDCORapid MonitorAddition of the LIDCORapid Monitor to measure stroke volume | Device | Study patients |
Primary outcome
stroke volume
Time frame: 1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days
measurement of stroke volume after each bolus of fluid has been given
Cardiac out-put
Time frame: 1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days
If Cardiac output increased by 15% then the patient is defined as a "fluid responder" and should receive more fluid. If there is not a 15% increase, then the patient will have no benefit from further fluid loading.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No. No plan to make IPD available
Related trials for Cardiac Output, Low
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingObservational study
Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients
Carbon Dioxide
RecruitingObservational study
Performance of Carbon Dioxide (CO2)-Derived Parameters in Predicting Low Cardiac Output Syndrome
Low Cardiac Output Syndrome Bypass Children
Recruiting
Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery
Heart Disease
Enrolling by invitation
LBBP + CSP Versus LBBP Alone for Cardiac Resynchronization Therapy
Heart Failure Low Output
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.
Andrew MacDuff principal investigator
The Royal Wolverhampton NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Small fluid boluses of 50 ml and LIDCORapid Monitor in people with Cardiac Output, Low and Cardiac Output, High, run by The Royal Wolverhampton Hospitals NHS Trust.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
stroke volume (time frame: 1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days). The study lists 2 primary outcomes in all. 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 11 May 2022.