The Use of LiDCOplus in Fluid Resuscitation Decision-Making

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349749
• Other study ID #: GN16CC090
• Status: Completed
• Phase: N/A
• First received: October 25, 2017
• Last updated: November 20, 2017
• Start date: March 22, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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