Peri-operative Fluid ManagementNCT03300323
Response to Varying the Rate of Administration of a Fluid Challenge
A study testing IV fluid challenge administration in people with Peri-operative Fluid Management, run by St George's Healthcare NHS Trust.
Trial summary
Administration of intravenous fluids is a key step in the management of the post-operative patient. Fluid management has been identified as one area that can affect rates of post-operative complications and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-operative Fluid Management
- What is being tested?
- IV fluid challenge administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Feb 2018
- 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
- Elective surgical patients admitted post-operatively to the General and Cardiothoracic Intensive Care Unit, requiring optimization with fluid therapy, as per the current clinical indications.
- Adult patients, aged >18 years, who have given informed consent to participate in the study.
Who cannot join
- Patients without capacity to consent for themselves
- Patients requiring aggressive fluid resuscitation due to life-threatening cardiovascular instability, such would not allow for period of observation for stability as defined in protocol.
- Pregnancy
- Possible contraindications to the use of the cardiac output monitoring device, or pathology known to affect accuracy of readings, including
- Extensive peripheral arterial occlusive disease in upper limbs
- Postoperative valvular insufficiency
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- New onset arrhythmia
- Cardiac assist device
- Right ventricular failure, (formal pre-operative diagnosis)
- Severe left ventricular failure or diastolic dysfunction
Trial locations and contacts
No sites are listed yet.
Maurizio Cecconi contact
About this study
Official title: The Impact of Different Rates of Administration of a Fluid Challenge on the Proportion of Responders and Non-responders in the Post-operative Patient
Administration of intravenous fluids is a key step in the management of the post-operative patient. Fluid management has been identified as one area that can affect rates of post-operative complications and outcomes. It is important to give the right amount of fluid, enough to optimise cardiovascular function, but not so much that we flood the cells. To guide this, we use a fluid challenge, administration of a small amount of fluid to test the cardiovascular response. At present there is significant inter-user variability in the method of administration of a fluid challenge. To ensure accuracy and reliability in assessing the response to a fluid challenge, the optimal method of administration needs to be determined.
The aim of this study is to investigate the optimal rate to give a fluid challenge over. Patients will be randomised to receive a fluid challenge over either 5 or 20 minutes. Both of these rates are within the currently accepted range. All patients will receive a dose of 4ml/kg of intravenous fluid. Previous work has shown this to be the optimal dose to reliably stress the system.
Read more
Measurement of the mean pressure in the cardiovascular system (mean systemic filling pressure or Pmsf) during the administration of a fluid challenge will be used to assess which rate of administration effectively challenges the cardiovascular system. Pmsf is measured using a pneumatic tourniquet inflated for sixty seconds, above an arterial line. The invasive arterial pressure is observed to then determine Pmsf. Cardiac output will also be monitored during and after administration of the fluid challenge. Since the microcirculation may remain impaired despite stabilisation of the macrocirculation, we will also observe this at baseline, on completion of the fluid challenge, and at 5 minute intervals for 15 minutes. This is observed using a handheld camera placed under the tongue.
The hypothesis is that administration of a fluid challenge at a faster rate, over 5 minutes as opposed to 20 minutes, will be a more effective test of the cardiovascular response. An effective fluid challenge is defined as one that causes a significant rise in mean systemic filling pressure. As such, a higher proportion of responders will be seen in response to the faster rate of fluid challenge. A responder is defined by an increase in cardiac output or stroke volume of more than 10% from baseline in response to a fluid challenge.
- Conditions
- Peri-operative Fluid Management
- Being tested
- IV fluid challenge administration
- Keywords
- peri-operative, fluid, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV fluid challenge administrationDiagnostic test
Administration of an intravenous fluid challenge to assess for fluid responsiveness
| Study group | Role | What they receive |
|---|---|---|
| IV Fluid challenge administration _5 | Active comparator | 4ml/kg intravenous fluid challenge administered over 5 minutes Receives: Diagnostic Test: IV fluid challenge administration |
| IV Fluid challenge administration 20 | Active comparator | 4ml/kg intravenous fluid challenge administered over 20 minutes Receives: Diagnostic Test: IV fluid challenge administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response to fluid administration - SV and/or CO response
A response is defined by an increase in SV and/or CO by more than 10% from the starting point of fluid administration Patients are randomised to two groups and administrated fluid at two different rates. The proportions of responders in the two groups are compared.
Measured: 35 minutes
Secondary outcomes (4)
Pharmacodynamic response to fluid administration - mean systemic filling pressure (Pmsf)
The pharmacodynamic response to fluids, in terms of maximum change and duration of change in Pmsf with different rates of fluid administration.
Measured: 35 minutes
Pharmacodynamic response to fluid administration - cardiac output
The pharmacodynamic response to fluids, in terms of maximum change and duration of change in CO with different rates of fluid administration.
Measured: 35 minutes
Pharmacodynamic response to fluid administration - blood pressure
The pharmacodynamic response to fluids, in terms of maximum change and duration of change in arterial blood pressure with different rates of fluid administration.
Measured: 35 minutes
Microcirculation
The response seen within the microcirculation with varying the rate of administration of the fluid challenge.
Measured: 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study startOct 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-operative Fluid ManagementStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Cecconi, Study chair, St George's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300323
- Sponsor's protocol ID
- 17.0092
- Status last verified
- Oct 2017
- First submitted
- 14 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Rates of Administration of a Fluid Challenge on the Proportion of Responders and Non-responders in the Post-operative Patient
- ClinicalTrials.gov ID
- NCT03300323
- Acronym / sponsor ID
- 17.0092
- Conditions
- Peri-operative Fluid Management
- Keywords
- peri-operative, fluid, microcirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St George's Healthcare NHS TrustUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 3 Oct 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.
Administration of intravenous fluids is a key step in the management of the post-operative patient. Fluid management has been identified as one area that can affect rates of post-operative complications and outcomes. It is important to give the right amount of fluid, enough to optimise cardiovascular function, but not so much that we flood the cells. To guide this, we use a fluid challenge, administration of a small amount of fluid to test the cardiovascular response. At present there is significant inter-user variability in the method of administration of a fluid challenge. To ensure accuracy and reliability in assessing the response to a fluid challenge, the optimal method of administration needs to be determined.
The aim of this study is to investigate the optimal rate to give a fluid challenge over. Patients will be randomised to receive a fluid challenge over either 5 or 20 minutes. Both of these rates are within the currently accepted range. All patients will receive a dose of 4ml/kg of intravenous fluid. Previous work has shown this to be the optimal dose to reliably stress the system.
Measurement of the mean pressure in the cardiovascular system (mean systemic filling pressure or Pmsf) during the administration of a fluid challenge will be used to assess which rate of administration effectively challenges the cardiovascular system. Pmsf is measured using a pneumatic tourniquet inflated for sixty seconds, above an arterial line. The invasive arterial pressure is observed to then determine Pmsf. Cardiac output will also be monitored during and after administration of the fluid challenge. Since the microcirculation may remain impaired despite stabilisation of the macrocirculation, we will also observe this at baseline, on completion of the fluid challenge, and at 5 minute intervals for 15 minutes. This is observed using a handheld camera placed under the tongue.
The hypothesis is that administration of a fluid challenge at a faster rate, over 5 minutes as opposed to 20 minutes, will be a more effective test of the cardiovascular response. An effective fluid challenge is defined as one that causes a significant rise in mean systemic filling pressure. As such, a higher proportion of responders will be seen in response to the faster rate of fluid challenge. A responder is defined by an increase in cardiac output or stroke volume of more than 10% from baseline in response to a fluid challenge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Fluid challenge administration _5 | Active comparator | Diagnostic Test: IV fluid challenge administration4ml/kg intravenous fluid challenge administered over 5 minutes |
| IV Fluid challenge administration 20 | Active comparator | Diagnostic Test: IV fluid challenge administration4ml/kg intravenous fluid challenge administered over 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective surgical patients admitted post-operatively to the General and Cardiothoracic Intensive Care Unit, requiring optimization with fluid therapy, as per the current clinical indications.
- Adult patients, aged >18 years, who have given informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Patients without capacity to consent for themselves
- Patients requiring aggressive fluid resuscitation due to life-threatening cardiovascular instability, such would not allow for period of observation for stability as defined in protocol.
- Pregnancy
- Possible contraindications to the use of the cardiac output monitoring device, or pathology known to affect accuracy of readings, including
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 |
|---|---|---|
| IV fluid challenge administrationAdministration of an intravenous fluid challenge to assess for fluid responsiveness | Diagnostic test | IV Fluid challenge administration 20, IV Fluid challenge administration _5 |
Primary outcome
Clinical response to fluid administration - SV and/or CO response
Time frame: 35 minutes
A response is defined by an increase in SV and/or CO by more than 10% from the starting point of fluid administration Patients are randomised to two groups and administrated fluid at two different rates. The proportions of responders in the two groups are compared.
4 secondary outcomes
Pharmacodynamic response to fluid administration - mean systemic filling pressure (Pmsf)
Time frame: 35 minutes
Pharmacodynamic response to fluid administration - cardiac output
Time frame: 35 minutes
Pharmacodynamic response to fluid administration - blood pressure
Time frame: 35 minutes
Microcirculation
Time frame: 35 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: No
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.
Maurizio Cecconi contact
Maurizio Cecconi study chair
St George's University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing IV fluid challenge administration in people with Peri-operative Fluid Management, run by St George's Healthcare 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Bennett (02087250399, v.bennett1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response to fluid administration - SV and/or CO response (time frame: 35 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 3 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.