Fluid Challenge and Plasma Volume, During Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.

Conditions
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Colorectal Cancer, Urologic Cancer, Gynecologic Cancer, Colorectal Disorders, Benign Neoplasm

Intervention / Treatment
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* Drug: acetated Ringers
* Drug: albumin 5%
* Drug: albumin 20%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acetated Ringers<br>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<br>* 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.<br>* Other names: acetate Ringer´s;|
| Experimental: albumin 5%<br>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%<br>* 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.<br>* Other names: Human Albumin 5%;|
| Experimental: albumin 20%<br>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%<br>* 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.<br>* Other names: Albumin (Human) 20%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma volume expansion after a fluid bolus | Plasma volume using hemoglobin as an indicator of dilution | 60 minutes after an intravenous fluid bolus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Balance | Calculations of fluid balance | 18 to 24 hours | 
| Stroke Volume | Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM)) | 60 minutes after an intravenous fluid bolus | 
| Arterial Blood Pressure | Mean Arterial Pressure, measured with an arterial line. | 60 minutes after an intravenous fluid bolus | 
| Heart Rate | Heart rate, measured with ECG and pulseoximeter. | 60 minutes after an intravenous fluid bolus | 
| Bioimpedance | Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments. | 18 to 24 hours | 
| Serum Creatinin | Serum Creatinin as a measure of kidney function | 18 to 24 hours | 
| arterial pH | Influence of a fluid bolus on arterial blood gases | 60 minutes after an intravenous fluid bolus | 
| arterial Base Excess | Influence of a fluid bolus on arterial blood gases | 60 minutes after an intravenous fluid bolus | 
| arterial serum sodium | Influence of a fluid bolus on Sodium concentration | 60 minutes after an intravenous fluid bolus | 
| arterial serum chloride | Influence of a fluid bolus on Chloride concentrations | 60 minutes after an intravenous fluid bolus | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic surgery, fluid therapy, plasma volume