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FC-VE: Fluid Challenge and Plasma Volume, During Surgery

Sponsor
Joachim Zdolsek (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05726136
Collaborator
(none)
60
Enrollment
3
Arms
22.5
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: acetated Ringers
  • Drug: albumin 5%
  • Drug: albumin 20%
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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%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)
Primary Purpose:
Treatment
Official Title:
Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: acetated Ringers

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.

Drug: acetated Ringers
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.
Other Names:
  • Ringer's acetate
  • ringer acetate
  • acetate Ringer´s

    		•
    Experimental: albumin 5%

    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.

    Drug: albumin 5%
    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.
    Other Names:
  • Albumin (Human) 5%
  • Human Albumin 5%

    		•
    Experimental: albumin 20%

    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.

    Drug: albumin 20%
    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.
    Other Names:
  • Human Albumin 20%
  • Albumin (Human) 20%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma volume expansion after a fluid bolus [60 minutes after an intravenous fluid bolus]

      Plasma volume using hemoglobin as an indicator of dilution

    Secondary Outcome Measures

    1. Fluid Balance [18 to 24 hours]

      Calculations of fluid balance

    2. Stroke Volume [60 minutes after an intravenous fluid bolus]

      Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))

    3. Arterial Blood Pressure [60 minutes after an intravenous fluid bolus]

      Mean Arterial Pressure, measured with an arterial line.

    4. Heart Rate [60 minutes after an intravenous fluid bolus]

      Heart rate, measured with ECG and pulseoximeter.

    5. Bioimpedance [18 to 24 hours]

      Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.

    6. Serum Creatinin [18 to 24 hours]

      Serum Creatinin as a measure of kidney function

    7. arterial pH [60 minutes after an intravenous fluid bolus]

      Influence of a fluid bolus on arterial blood gases

    8. arterial Base Excess [60 minutes after an intravenous fluid bolus]

      Influence of a fluid bolus on arterial blood gases

    9. arterial serum sodium [60 minutes after an intravenous fluid bolus]

      Influence of a fluid bolus on Sodium concentration

    10. arterial serum chloride [60 minutes after an intravenous fluid bolus]

      Influence of a fluid bolus on Chloride concentrations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Joachim Zdolsek

    Investigators

    • Principal Investigator: Joachim Zdolsek, MD PhD, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Joachim Zdolsek, consultant, assoc prof, University Hospital, Linkoeping
    ClinicalTrials.gov Identifier:
    NCT05726136
    Other Study ID Numbers:
    • FC-VE
    First Posted:
    Feb 13, 2023
    Last Update Posted:
    Feb 13, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Joachim Zdolsek, consultant, assoc prof, University Hospital, Linkoeping
    laparoscopic surgery, fluid therapy, plasma volume
    Additional relevant MeSH terms:
    Neoplasms
    Urologic Neoplasms

    Study Results

    No Results Posted as of Feb 13, 2023