Does the Use of LiDCOplus Alter Decision-making in Fluid Prescription During Resuscitation in the Intensive Care Unit.
Conditions: Shock
Sponsor: NHS Greater Glasgow and Clyde

Use of LiDCOplus in Fluid Resuscitation Decision-Making           
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Title 
 
· 
Does the use of LiDCOplus alter decision-making in fluid prescription during 
resuscitation in the Intensive Care Unit? 
Or  Use of LiDCOplus in Fluid Resuscitation Decision-Making 
 
Introduction 
 
· 
Rationale 
 
Unwell patients in the intensive care unit (ICU) often need supplementary fluids to be
given into the bloodstream through a drip in a vein (venous cannula), however too  
much fluid can be harmful. It can sometimes be difficult to tell whether or not a  
patient will benefit from extra fluids so they are given a "fluid challenge", whereby a  
small volume of fluid is given quickly into the cannula and the change in their status  
is noted. If the patient’s condition improves, this suggests that the patient is “fluid  
responsive” and needs more fluid.  
 
A LiDCOplus cardiac output monitor is a device used in the ICU to estimate the  
amount of blood ejected from the heart on each heartbeat using pressure readings  
obtained from a tube placed in one of the patient's arteries (arterial line).  
 
We aim to determine whether or not the use of this device called makes a difference 
to the judgement of “fluid responsiveness” when the patient is given a fluid challenge
when compared to simply using measurements of pulse and blood pressure and  
assessing the circulation in the patient's limbs. This will allow us to determine  
whether or not the LiDCOplus cardiac output monitor alters the decisions made by  
doctors and nurses about how much fluid to give their patients and hence if it is of 
any benefit.  
  
· 
Background information including literature review 
 
In the published literature there are multiple studies using the LiDCOplus-derived 
change in stroke volume as a gold standard of fluid responsiveness against other 
measures such as stroke volume variation and pulse pressure variation1,2.  However 
there do not seem to be any studies evaluating the change in stroke volume itself as a 
measure of fluid responsiveness against clinical parameters, as proposed in the current 
study. 
 
There are two studies which compare outcomes in patients whose fluid therapy was 
guided by LiDCO vs controls. One was a pilot study of 21 severely burned adults which 
compared fluid therapy in patients with and without LiDCO monitoring and showed that 
the LiDCO group received significantly less fluid3. The other was a study on intra-
operative patients undergoing surgical repair of fractured neck of femur under spinal 
anaesthetic4 and is not relevant to the critically unwell patients in the intensive care 
unit we wish to study. 
 
There does, therefore, appear to be a lack of current evidence to address the research 
question and further research in to this area would be desirable. 
 
· 
Potential risk and benefits 
Study Protocol  
(including Statistical Analysis plan) 
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The results of this study should benefit patients in ICU by evaluating the usefulness 
of a piece of equipment used regularly to guide patient care. If it is shown to be 
useful, this may encourage its use in order to gain maximum benefit for patients. If it 
is shown not to be useful, this may lead to a reduction in its use and subsequent cost 
savings to ICU departments which can use the extra money to improve patient care 
in other areas. 
 
There is minimal potential for direct benefit to patients as the research does not 
involve any change to their standard monitoring and treatment. However, there may 
be a benefit in the special attention paid to the patients' response to fluids e.g. 
minimising errors and picking up additional information from the patient's 
assessment. 
 
There are minimal potential risks for research participants as their monitoring or 
treatment will not be affected apart from a very brief delay while the clinician fills out 
the research proforma by the bedside. 
 
· 
Prior experience of intervention 
 
The LiDCOplus device is widely used in the authors’ intensive care unit to guide fluid 
therapy in patients requiring fluid resuscitation. It is thought that this allows 
administered fluid volumes to be tailored to maximize benefit and minimise harm to 
the patient it is not entirely clear from clinical experience whether or not this is the 
case. 
 
· 
Study Hypothesis 
 
The Null Hypothesis is there is no difference to the judgement of "fluid responsiveness" 
using information from a LiDCOplus monitor when a patient is given a fluid challenge, 
when compared to simply using standard clinical measurements of responsiveness. 
 
Aim/Primary and Secondary Objectives 
 
· 
Primary Endpoint 
To determine whether or not use of the LiDCOplus cardiac output monitor results in 
an estimate of a patient's response to a fluid challenge which is significantly different 
to that simply obtained using standard measures of blood pressure, heart rate and 
limb circulation. 
· 
Secondary endpoints 
[None] 
 

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Methodology 
 
A patient undergoing fluid resuscitation guided by a LiDCOplus device will have a research 
data pro forma left at their bedside along with instructions on how to complete it. When a 
patient is given a fluid challenge (the fast intravenous administration of 250ml of Hartmann’s 
solution) as part of their routine management, a number of additional actions will take place. 
The screen of the LiDCOplus will be covered up initially and baseline heart rate, blood 
pressure and subjective assessment of limb circulation will be recorded on the proforma. 
After the fluid challenge is administered the above observations will be recorded again and at 
this point an assessment of whether the patient is “responsive” or “unresponsive” will be 
made. The LiDCOplus screen will then be uncovered and the change in stroke volume will be 
recorded (the cut off for being fluid responsive is a change of >10%). Finally, an overall 
decision regarding fluid responsiveness is made and recorded, along with the grade of 
decision maker (e.g. staff nurse or consultant). 
 
This observational study will be performed according to the Research Governance Framework 
for Health and Community Care (Second edition, 2006). 
 
Study Population 
 
The study population will be a convenience sample as appropriate to the study type so the 
exact number of participants is not known as yet. 
 
We aim to include all patients undergoing fluid resuscitation using a LiDCOplus cardiac output
 monitor in Glasgow Royal Infirmary Intensive Care Unit during the study period.  
  
The researchers will regularly review the patients on the ICU to identify suitable participants.  
 
 
Inclusion criteria 
 
· 
Adult patients 
· 
Admitted to Intensive Care Unit (ICU) 
· 
Undergoing fluid resuscitation guided by fluid challenges 
· 
Monitored by a LiDCOplus cardiac output monitor attached to an arterial line 
 
Exclusion criteria 
 
· 
Poor arterial line trace 
· 
Moribund state 
· 
Patient / relative refusal 
· 
Contra-indication to fluid bolus 
 
Identification of participants and consent 
 
All eligible patients as per the inclusion and exclusion criteria will be identified and included in 
the study, which will simply involve a single-sheet pro forma being placed at their bedside for 
the clinical staff to complete when the patient undergoes a fluid challenge. 
 
The direct care team will carry out the data gathering by completing the pro forma and the 
research team (who are part of the clinical team) will also be involved to remind the rest of 
the clinical team about the study and ensure any questions are answered. 
 
Given that the patients will not experience any difference in their care but the clinical staff will 
have to perform some extra steps when administering a fluid challenge, it is the clinical staff 
(nurses and doctors) involved who will be asked for their informed consent to take part in the 
study. 

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Study Outcome Measures 
 
4.1 
Primary Outcome Measure 
 
Proportion of decisions about fluid management changed by knowledge of the  
change in stroke volume post fluid challenge, as derived by LiDCO cardiac output  
monitor. 
4.2. 
Secondary Outcome Measure 
 
None 
 
 
Statistics and Data Analysis  
 
As this is a descriptive study only descriptive statistics will be used, i.e. the proportion of 
patients deemed fluid-responsive by the use of LiDCOplus versus standard parameters alone and the 
proportion of fluid responsiveness decisions altered when the information from the LiDCOplus is 
taken into account. 
 
STUDY CLOSURE / DEFINITION OF END OF TRIAL 
The study will end when the planned sample size has been achieved. 
 
Protocol Amendments 
Any change in the study protocol will require an amendment.  Any proposed protocol 
amendments will be initiated by the CI following discussion with the TSC and any required 
amendment forms will be submitted to the regulatory authority, ethics committee and 
sponsor.  The CI and the TSC will liaise with study sponsor to determine whether an 
amendment is non-substantial or substantial.  All amended versions of the protocol will be 
signed by the CI and Sponsor representative.  Before the amended protocol can be 
implemented favourable opinion/approval must be sought from the original reviewing REC 
and Research and Development (R&D) office(s). 
 
Ethics 
 
The study will be carried out in accordance with the World Medical Association Declaration of 
Helsinki (1964) and its revisions (Tokyo [1975], Venice [1983], Hong Kong [1989], South 
Africa [1996] and Edinburgh[2000]). 
 
Favourable ethical opinion will be sought from an appropriate REC before patients are 
entered into this study.   
 
The CI will be responsible for updating the Ethics committee of any new information related 
to the study. 
 
Finance and Indemnity 
 
NHS employed researchers will be covered for negligent harm through the NHS CNORIS 
indemnity scheme. If you are a University employee you may need extra cover for non-
negligent harm through your University. Please check this with your Research and Enterprise 
department. 
 
The study is sponsored by NHS Greater Glasgow & Clyde.  The sponsor will be liable for 
negligent harm caused by the design of the trial.  NHS indemnity is provided under the 
Clinical Negligence and Other Risks Indemnity Scheme (CNORIS). 
 
 
Publications 
 

Use of LiDCOplus in Fluid Resuscitation Decision-Making           
Research Governance Protocol Version 1.2 
 
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Study results whether, negative or positive, should be disseminated.  Details of your plan for 
dissemination should be included here. 
 
Reference 
 
1. MacDonald N, Ahmad T, Mohr O, Kirk-Bayley J, Moppett I, Hinds CJ, Pearse RM. 
Dynamic preload markers to predict fluid responsiveness during and after major 
gastrointestinal surgery: an observational substudy of the OPTIMISE trial. Br J 
Anaesth. 2015 Apr;114(4):598-604 
 
2. Drvar Z, Pavlek M, Drvar V, Tomasević B, Baronica R, Perić M. [Stroke volume and 
pulse pressure variation are good predictors of fluid responsiveness in sepsis 
patients]. Acta Med Croatica. 2013 Dec;67(5):407-14. 
 
3. Tokarik M, Sjöberg F, Balik M, Pafcuga I, Broz L.Fluid therapy LiDCO controlled trial-
optimization of volume resuscitation of extensively burned patients through 
noninvasive continuous real-time hemodynamic monitoring LiDCO. J Burn Care Res. 
2013 Sep-Oct;34(5):537-42. 
 
4. Moppett IK, Rowlands M, Mannings A, Moran CG, Wiles MD; NOTTS Investigators. 
LiDCO-based fluid management in patients undergoing hip fracture surgery under 
spinal anaesthesia: a randomized trial and systematic review. Br J Anaesth. 2015 
Mar;114(3):444-59.