Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03058653 |
| Other study ID # |
2017CRI89 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2021 |
| Est. completion date |
October 2022 |
Study information
| Verified date |
May 2022 |
| Source |
The Royal Wolverhampton Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
