search
Back to results

Use of a Mini-fluid Bolus to Identify Fluid Responsiveness

Primary Purpose

Cardiac Output, Low, Cardiac Output, High

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Small fluid boluses of 50 ml
LIDCORapid Monitor
Sponsored by
The Royal Wolverhampton Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Output, Low

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study patients

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    May 5, 2022
    Sponsor
    The Royal Wolverhampton Hospitals NHS Trust
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03058653
    Brief Title
    Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
    Official Title
    Use of a Mini-fluid Bolus to Identify Fluid Responsiveness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Covid-19
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Royal Wolverhampton Hospitals NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters will be approached. Reasons for fluid administration include evidence of inadequate tissue perfusion such as raised blood lactate or poor urine output, hypotension or attempts to wean vasopressor dose. Patients will be identified as suitable for inclusion by the Consultant Responsible for the Intensive Care Unit on each day. As fluid responsiveness is a transient phenomenon which disappears after significant fluid resuscitation it is proposed that patients will be immediately entered into the study so that the study contains a mix of fluid responsive and non-responsive patients in order to get the time critical data required which may be lost if there is a significant delay before study entry. Informed consent will be sought from the patient, or if they are incapacitated by critical illness, their relative will be approached for assent as soon as possible and within 48 hours of study enrollment. This is in line with recommendations for Research involving emergency treatment. The LiDCOrapid machine will be connected in the same manner as the LiDCOplus machine, currently in use on ICU, in order to obtain the stroke volume measurement. A smartcard is inserted and the patient details entered. Monitoring will continue until fluids are clinically indicated. Patients will be given fluid boluses via either peripheral or central venous catheters. The following data will be collected for each patient: Age, Gender, Height, Weight, diagnosis requiring ICU admission, location of venous and arterial catheters, APACHE II scores, Cumulative fluid balance at time of bolus administration, Ventilation status (self-ventilating, non-invasive ventilation, invasive ventilation and mode if appropriate), tidal volume if measured, drugs being infused (sedatives, inotropes, vasoactive drugs, diuretics, muscle relaxants, etc), presence of renal replacement therapy. Fluid administration protocol: Patients will be monitored just prior to infusion for hemodynamic stability, Standard practice is to administer a bolus of 500ml given via an infusion pump at a rate of 1200mL/hour (25min). For study patients the first 250ml will be given in 50ml boluses using a 50ml syringe. Each bolus will be given over approximately 1 minute and the study measurements will be recorded followed by a wait for response of 1 minute. This will be repeated for each subsequent bolus until 250ml has been given (i.e. 5 boluses). The remaining 250ml will be given via the standard 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. At the end of each bolus Stroke volume, cardiac output, heart rate, blood pressure will be determined. Up to 2 sets of data per patient per day will be collected. The majority of patients routinely stay in the ICU for 2 days, while in a smaller group, for much longer. A maximum of 4 data sets will be collected per patient. The fluid boluses will be administered at the discretion of the treating physician who believes that they will improve the clinical condition of the patient. The study team will have no influence on the timing of these.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Output, Low, Cardiac Output, High

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study patients
    Arm Type
    Experimental
    Arm Description
    Small fluid boluses - The first 250ml of fluid will be given in 50ml boluses using a 50ml syringe
    Intervention Type
    Procedure
    Intervention Name(s)
    Small fluid boluses of 50 ml
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    LIDCORapid Monitor
    Intervention Description
    Addition of the LIDCORapid Monitor to measure stroke volume
    Primary Outcome Measure Information:
    Title
    stroke volume
    Description
    measurement of stroke volume after each bolus of fluid has been given
    Time Frame
    1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days
    Title
    Cardiac out-put
    Description
    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.
    Time Frame
    1 minute intervals for 10 mins, then at 25 mins over 4 episodes in 2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients whom the Consultant Intensivist decides should receive a fluid challenge as part of their standard care in order to improve haemodynamic parameters Exclusion Criteria: Age under 18 severe haemodynamic instability persistent arrhythmia (including atrial fibrillation) pregnant patients palliative care only patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew MacDuff
    Organizational Affiliation
    The Royal Wolverhampton NHS Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plan to make IPD available

    Learn more about this trial

    Use of a Mini-fluid Bolus to Identify Fluid Responsiveness

    We'll reach out to this number within 24 hrs