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The Use of LiDCOplus in Fluid Resuscitation Decision-Making

NCT ID: NCT03349749

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-22

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Shock

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients undergoing fluid resuscitation

Adult patients in the intensive care unit (ICU) undergoing fluid resuscitation guided by the LiDCOplus haemodynamic monitor.

LiDCOplus haemodynamic monitor

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James A Patterson, MBChB

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

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Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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GN16CC090

Identifier Type: -

Identifier Source: org_study_id