Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
Primary Purpose
Cardiac Output, Low, Cardiac Output, High
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Small fluid boluses of 50 ml
LIDCORapid Monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Output, Low
Eligibility Criteria
Inclusion Criteria:
- Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters
Exclusion Criteria:
- Age under 18
- severe haemodynamic instability
- persistent arrhythmia (including atrial fibrillation)
- pregnant patients
- palliative care only patients
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study patients
Arm Description
Small fluid boluses - The first 250ml of fluid will be given in 50ml boluses using a 50ml syringe
Outcomes
Primary Outcome Measures
stroke volume
measurement of stroke volume after each bolus of fluid has been given
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03058653
First Posted
February 7, 2017
Last Updated
May 5, 2022
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03058653
Brief Title
Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
Official Title
Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Covid-19
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Wolverhampton Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Low, Cardiac Output, High
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study patients
Arm Type
Experimental
Arm Description
Small fluid boluses - The first 250ml of fluid will be given in 50ml boluses using a 50ml syringe
Intervention Type
Procedure
Intervention Name(s)
Small fluid boluses of 50 ml
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LIDCORapid Monitor
Intervention Description
Addition of the LIDCORapid Monitor to measure stroke volume
Primary Outcome Measure Information:
Title
stroke volume
Description
measurement of stroke volume after each bolus of fluid has been given
Time Frame
1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days
Title
Cardiac out-put
Description
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.
Time Frame
1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters
Exclusion Criteria:
Age under 18
severe haemodynamic instability
persistent arrhythmia (including atrial fibrillation)
pregnant patients
palliative care only patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew MacDuff
Organizational Affiliation
The Royal Wolverhampton NHS Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make IPD available
Learn more about this trial
Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
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