Fluid Challenge and Plasma Volume, During Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: acetated Ringers, albumin 5%, albumin 20%.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Urologic Cancer, Gynecologic Cancer, Colorectal Disorders. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
Overview
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
- 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. - 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. - 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.
Primary outcome measures
- Plasma volume expansion after a fluid bolus [Time frame: 60 minutes after an intravenous fluid bolus]
Secondary outcome measures (10)
- Fluid Balance [Time frame: 18 to 24 hours]
- Stroke Volume [Time frame: 60 minutes after an intravenous fluid bolus]
- Arterial Blood Pressure [Time frame: 60 minutes after an intravenous fluid bolus]
- Heart Rate [Time frame: 60 minutes after an intravenous fluid bolus]
- Bioimpedance [Time frame: 18 to 24 hours]
- Serum Creatinin [Time frame: 18 to 24 hours]
- arterial pH [Time frame: 60 minutes after an intravenous fluid bolus]
- arterial Base Excess [Time frame: 60 minutes after an intravenous fluid bolus]
- arterial serum sodium [Time frame: 60 minutes after an intravenous fluid bolus]
- arterial serum chloride [Time frame: 60 minutes after an intravenous fluid bolus]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Vrinnevi Hospital — Norrköping
Identifiers
NCT: NCT05726136 · FC-VE