The Use of LiDCOplus in Fluid Resuscitation Decision-Making

Does the Use of LiDCOplus Alter Decision-making in Fluid Prescription During Resuscitation in the Intensive Care Unit.

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 haemodynamic 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).

The investigators 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 the investigators to determine whether or not the LiDCOplus alters the decisions made by doctors and nurses about how much fluid to give their patients and hence if it is of any benefit.

Study Overview

• Status: Completed
• Conditions: Shock
• Intervention / Treatment: Device: LiDCOplus haemodynamic monitor

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G4 0SF
    • Glasgow Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients in the Intensive Care Unit (ICU) undergoing fluid resuscitation guided by fluid challenges monitored by a LiDCOplus haemodynamic monitor.

Description

Inclusion Criteria:

• Adult patients
• Admitted to Intensive Care Unit (ICU)
• Undergoing fluid resuscitation guided by fluid challenges
• Monitored by a LiDCOplus haemodynamic monitor attached to an arterial line

Exclusion Criteria:

• Poor arterial line trace
• Moribund state
• Patient / relative refusal
• Contra-indication to fluid bolus

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing fluid resuscitation; Adult patients in the intensive care unit (ICU) undergoing fluid resuscitation guided by the LiDCOplus haemodynamic monitor.	Device: LiDCOplus haemodynamic monitor; Patients in study group receive intravenous fluid bolus as part of standard fluid resuscitation. Fluid responsiveness (i.e. improvement in cardiac output) is estimated using both standard clinical parameters and by LiDCOplus haemodynamic monitor (with the clinician initially blinded to the latter) before a final decision about fluid responsiveness is made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid responsiveness decisions changed by use of LiDCOplus	Proportion of decisions about fluid management changed by knowledge of the change in stroke volume post fluid challenge, as derived by LiDCOplus haemodynamic monitor.	10 minutes

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: James A Patterson, MBChB, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: intensive care units; cardiac output; resuscitation; fluid therapy; monitoring, physiologic; Vascular Access Devices
• Other Study ID Numbers: GN16CC090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No