Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- stroke volume
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported