Colorectal Cancer, Urologic Cancer, Gynecologic Cancer, Colorectal Disorders, Benign Neoplasm
Conditions
Keywords
laparoscopic surgery, fluid therapy, plasma volume
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.
Interventions
DRUGacetated 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.
DRUGalbumin 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.
DRUGalbumin 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.
Sponsors
Joachim Zdolsek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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%
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma volume expansion after a fluid bolus | 60 minutes after an intravenous fluid bolus | Plasma volume using hemoglobin as an indicator of dilution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Volume | 60 minutes after an intravenous fluid bolus | Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM)) |
| Arterial Blood Pressure | 60 minutes after an intravenous fluid bolus | Mean Arterial Pressure, measured with an arterial line. |
| Heart Rate | 60 minutes after an intravenous fluid bolus | Heart rate, measured with ECG and pulseoximeter. |
| Bioimpedance | 18 to 24 hours | Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments. |
| Fluid Balance | 18 to 24 hours | Calculations of fluid balance |
| arterial pH | 60 minutes after an intravenous fluid bolus | Influence of a fluid bolus on arterial blood gases |
| arterial Base Excess | 60 minutes after an intravenous fluid bolus | Influence of a fluid bolus on arterial blood gases |
| arterial serum sodium | 60 minutes after an intravenous fluid bolus | Influence of a fluid bolus on Sodium concentration |
| arterial serum chloride | 60 minutes after an intravenous fluid bolus | Influence of a fluid bolus on Chloride concentrations |
| Serum Creatinin | 18 to 24 hours | Serum Creatinin as a measure of kidney function |
Countries
Sweden
Contacts
Primary ContactRobert Svensson, MD
Backup ContactHans Bahlmann, MD, PhD
Outcome results
None listed