Use of a Mini-fluid Bolus to Identify Fluid Responsiveness

NCT03058653 | Withdrawn

• 1 other identifier: 2017CRI89
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

On the Intensive Care Unit doctors give a lot of fluid to patients in order to improve their blood pressure, amount of urine made or to let doctors stop drugs that are needed to keep blood pressure up. Doctors normally give patients 500ml of fluid over 25 minutes as standard, however it is very difficult to know if giving those fluids and how much fluid will help (it does in some but not others). If a person gets too much fluid this can also cause problems such as fluid in lungs, poor kidney function, or swelling in the limbs. The LidCo Rapid monitor lets the Intensive Care Unit (ICU) team know the amount of blood the heart pushes out with each beat (Stroke volume). It works by following the tracing off the arterial line (Blood pressure monitor) that has been inserted as part of the standard care of a patient on the ICU. It does not need any other invasive procedures or drug administration to work. This study is using this monitor to see if it can identify a method of improving the administration of intravenous fluids on the Intensive Care Unit. The study is looking to see if it can identify whether giving a small amount of fluid first identifies people who will benefit from more fluid and those that won't.

Conditions

Cardiac Output, Low; Cardiac Output, High

Outcome Measures

Primary Outcomes (2)

• stroke volume

  measurement of stroke volume after each bolus of fluid has been given

  1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days

• Cardiac out-put

  If Cardiac output increased by 15% then the patient is defined as a "fluid responder" and should receive more fluid. If there is not a 15% increase, then the patient will have no benefit from further fluid loading.

  1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days

Study Arms (1)

Study patients

EXPERIMENTAL

Small fluid boluses - The first 250ml of fluid will be given in 50ml boluses using a 50ml syringe

Procedure: Small fluid boluses of 50 ml; Device: LIDCORapid Monitor

Interventions

Small fluid boluses of 50 ml PROCEDURE

Participants will receive small 50ml boluses of fluid up to 250ml in total. The remainder will be given as infusion pump method at a rate of 1000ml/hour which will complete in 15 minutes. In total, the 500ml will be given over 25 minutes.

Study patients

LIDCORapid Monitor DEVICE

Addition of the LIDCORapid Monitor to measure stroke volume

Study patients

Eligibility Criteria

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

You may qualify if:

• Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters

You may not qualify if:

• Age under 18
• severe haemodynamic instability
• persistent arrhythmia (including atrial fibrillation)
• pregnant patients
• palliative care only patients

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

MeSH Terms

Conditions

Cardiac Output, Low; Cardiac Output, High

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew MacDuff

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 23, 2017
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share