search
Back to results

Fluid Challenge and Plasma Volume, During Surgery (FC-VE)

Primary Purpose

Colorectal Cancer, Urologic Cancer, Gynecologic Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
acetated Ringers
albumin 5%
albumin 20%
Sponsored by
Joachim Zdolsek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring laparoscopic surgery, fluid therapy, plasma volume

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written consent to participate in the study For women: relevant contraceptive, menopausal or a negative pregnancy test. ASA category I to III Laparoscopic abdominal surgery, with a duration of at least 90 minutes. 18 to 80 years Exclusion Criteria: Patients with known cardiac failure <18 or >80 years known allergy to albumin extracellular hyperhydration or hypervolemia kidney failure pregnancy or planned pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    acetated Ringers

    albumin 5%

    albumin 20%

    Arm Description

    The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.

    The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied.

    The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.

    Outcomes

    Primary Outcome Measures

    Plasma volume expansion after a fluid bolus
    Plasma volume using hemoglobin as an indicator of dilution

    Secondary Outcome Measures

    Fluid Balance
    Calculations of fluid balance
    Stroke Volume
    Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))
    Arterial Blood Pressure
    Mean Arterial Pressure, measured with an arterial line.
    Heart Rate
    Heart rate, measured with ECG and pulseoximeter.
    Bioimpedance
    Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.
    Serum Creatinin
    Serum Creatinin as a measure of kidney function
    arterial pH
    Influence of a fluid bolus on arterial blood gases
    arterial Base Excess
    Influence of a fluid bolus on arterial blood gases
    arterial serum sodium
    Influence of a fluid bolus on Sodium concentration
    arterial serum chloride
    Influence of a fluid bolus on Chloride concentrations

    Full Information

    First Posted
    January 15, 2023
    Last Updated
    February 9, 2023
    Sponsor
    Joachim Zdolsek
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05726136
    Brief Title
    Fluid Challenge and Plasma Volume, During Surgery
    Acronym
    FC-VE
    Official Title
    Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Joachim Zdolsek

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.
    Detailed Description
    60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight. Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Urologic Cancer, Gynecologic Cancer, Colorectal Disorders, Benign Neoplasm
    Keywords
    laparoscopic surgery, fluid therapy, plasma volume

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    3 randomized parallel groups, with 20 patients in each group. Each group receives a prespecified fluid regime with: 1. acetated Ringers 2. albumin 5% or 3. albumin 20%
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    acetated Ringers
    Arm Type
    Experimental
    Arm Description
    The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
    Arm Title
    albumin 5%
    Arm Type
    Experimental
    Arm Description
    The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied.
    Arm Title
    albumin 20%
    Arm Type
    Experimental
    Arm Description
    The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
    Intervention Type
    Drug
    Intervention Name(s)
    acetated Ringers
    Other Intervention Name(s)
    Ringer's acetate, ringer acetate, acetate Ringer´s
    Intervention Description
    After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first fluid bolus is infused. Circulatory and volume effects are studied. If cardiac output increase a second bolus is infused and studied.
    Intervention Type
    Drug
    Intervention Name(s)
    albumin 5%
    Other Intervention Name(s)
    Albumin (Human) 5%, Human Albumin 5%
    Intervention Description
    After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
    Intervention Type
    Drug
    Intervention Name(s)
    albumin 20%
    Other Intervention Name(s)
    Human Albumin 20%, Albumin (Human) 20%
    Intervention Description
    After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
    Primary Outcome Measure Information:
    Title
    Plasma volume expansion after a fluid bolus
    Description
    Plasma volume using hemoglobin as an indicator of dilution
    Time Frame
    60 minutes after an intravenous fluid bolus
    Secondary Outcome Measure Information:
    Title
    Fluid Balance
    Description
    Calculations of fluid balance
    Time Frame
    18 to 24 hours
    Title
    Stroke Volume
    Description
    Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))
    Time Frame
    60 minutes after an intravenous fluid bolus
    Title
    Arterial Blood Pressure
    Description
    Mean Arterial Pressure, measured with an arterial line.
    Time Frame
    60 minutes after an intravenous fluid bolus
    Title
    Heart Rate
    Description
    Heart rate, measured with ECG and pulseoximeter.
    Time Frame
    60 minutes after an intravenous fluid bolus
    Title
    Bioimpedance
    Description
    Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.
    Time Frame
    18 to 24 hours
    Title
    Serum Creatinin
    Description
    Serum Creatinin as a measure of kidney function
    Time Frame
    18 to 24 hours
    Title
    arterial pH
    Description
    Influence of a fluid bolus on arterial blood gases
    Time Frame
    60 minutes after an intravenous fluid bolus
    Title
    arterial Base Excess
    Description
    Influence of a fluid bolus on arterial blood gases
    Time Frame
    60 minutes after an intravenous fluid bolus
    Title
    arterial serum sodium
    Description
    Influence of a fluid bolus on Sodium concentration
    Time Frame
    60 minutes after an intravenous fluid bolus
    Title
    arterial serum chloride
    Description
    Influence of a fluid bolus on Chloride concentrations
    Time Frame
    60 minutes after an intravenous fluid bolus

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written consent to participate in the study For women: relevant contraceptive, menopausal or a negative pregnancy test. ASA category I to III Laparoscopic abdominal surgery, with a duration of at least 90 minutes. 18 to 80 years Exclusion Criteria: Patients with known cardiac failure <18 or >80 years known allergy to albumin extracellular hyperhydration or hypervolemia kidney failure pregnancy or planned pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Svensson, MD
    Phone
    +4610142305
    Email
    robert.svensson@regionostergotland.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hans Bahlmann, MD, PhD
    Phone
    +46101031860
    Email
    hans.bahlmann@regionostergotland.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joachim Zdolsek, MD PhD
    Organizational Affiliation
    Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual de-identified results will be shared, when results are published.

    Learn more about this trial

    Fluid Challenge and Plasma Volume, During Surgery

    We'll reach out to this number within 24 hrs