Clinical trial NCT05726136: Fluid Challenge and Plasma Volume, During Surgery
Official title: Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Colorectal Cancer
Urologic Cancer
Gynecologic Cancer
Colorectal Disorders
Benign Neoplasm
Keywords: laparoscopic surgery, fluid therapy, plasma volume
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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%
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Plasma volume expansion after a fluid bolus
timeFrame: 60 minutes after an intravenous fluid bolus
Secondary outcomes:
measure: Fluid Balance
timeFrame: 18 to 24 hours
measure: Stroke Volume
timeFrame: 60 minutes after an intravenous fluid bolus
measure: Arterial Blood Pressure
timeFrame: 60 minutes after an intravenous fluid bolus
measure: Heart Rate
timeFrame: 60 minutes after an intravenous fluid bolus
measure: Bioimpedance
timeFrame: 18 to 24 hours
measure: Serum Creatinin
timeFrame: 18 to 24 hours
measure: arterial pH
timeFrame: 60 minutes after an intravenous fluid bolus
measure: arterial Base Excess
timeFrame: 60 minutes after an intravenous fluid bolus
measure: arterial serum sodium
timeFrame: 60 minutes after an intravenous fluid bolus
measure: arterial serum chloride
timeFrame: 60 minutes after an intravenous fluid bolus
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
state: Östergötland
Study officials:
affiliation: Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
name: Joachim Zdolsek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: