Colorectal Cancer Clinical Trial
— FC-VEOfficial title:
Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 31, 2025 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Vrinnevi Hospital | Norrköping | Östergötland |
Lead Sponsor | Collaborator |
---|---|
Joachim Zdolsek |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma volume expansion after a fluid bolus | Plasma volume using hemoglobin as an indicator of dilution | 60 minutes after an intravenous fluid bolus | |
Secondary | Fluid Balance | Calculations of fluid balance | 18 to 24 hours | |
Secondary | Stroke Volume | Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM)) | 60 minutes after an intravenous fluid bolus | |
Secondary | Arterial Blood Pressure | Mean Arterial Pressure, measured with an arterial line. | 60 minutes after an intravenous fluid bolus | |
Secondary | Heart Rate | Heart rate, measured with ECG and pulseoximeter. | 60 minutes after an intravenous fluid bolus | |
Secondary | Bioimpedance | Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments. | 18 to 24 hours | |
Secondary | Serum Creatinin | Serum Creatinin as a measure of kidney function | 18 to 24 hours | |
Secondary | arterial pH | Influence of a fluid bolus on arterial blood gases | 60 minutes after an intravenous fluid bolus | |
Secondary | arterial Base Excess | Influence of a fluid bolus on arterial blood gases | 60 minutes after an intravenous fluid bolus | |
Secondary | arterial serum sodium | Influence of a fluid bolus on Sodium concentration | 60 minutes after an intravenous fluid bolus | |
Secondary | arterial serum chloride | Influence of a fluid bolus on Chloride concentrations | 60 minutes after an intravenous fluid bolus |
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