Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
| Registry | NCT05726136, acronym FC-VE |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | Joachim Zdolsek (Other) |
| Conditions | Colorectal Cancer, Urologic Cancer, Gynecologic Cancer, Colorectal Disorders, Benign Neoplasm |
| Interventions | acetated Ringers, albumin 5%, albumin 20% (Drug) |
| Dates | start 2023-10-23, primary completion 2026-10-31 (estimated), completion 2026-10-31 (estimated), first posted 2023-02-13, last updated 2026-04-30 |
| Locations | 1 site in Sweden |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| acetated Ringers | Experimental | Drug: 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. |
| albumin 5% | Experimental | Drug: 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. |
| albumin 20% | Experimental | Drug: 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. |
Sex: All, ages: 18 Years to 85 Years
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 85 years Exclusion Criteria: * Patients with known cardiac failure * <18 or >85 years * known allergy to albumin * extracellular hyperhydration or hypervolemia * kidney failure * pregnancy or planned pregnancy
| Facility | City | Country | Status |
|---|---|---|---|
| Vrinnevi Hospital | Norrköping, Östergötland County | Sweden | Recruiting |