The Use of LiDCOplus in Fluid Resuscitation Decision-Making

NCT03349749 | Completed FDA Device

• 1 other identifier: GN16CC090
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock

Keywords

intensive care units; resuscitation; fluid therapy; Vascular Access Devices; cardiac output; monitoring, physiologic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

LiDCOplus haemodynamic monitor DEVICE

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.

Patients undergoing fluid resuscitation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James A Patterson, MBChB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 22, 2017
• Study Start: March 22, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)