Fluid Challenge and Plasma Volume, During Surgery

Trial Title: Fluid Challenge and Plasma Volume, During Surgery

NCT ID: NCT05726136

Condition: Colorectal Cancer
Urologic Cancer
Gynecologic Cancer
Colorectal Disorders
Benign Neoplasm

Conditions: Official terms:
Urologic Neoplasms
Neoplasms

Conditions: Keywords:
laparoscopic surgery, fluid therapy, plasma volume

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: acetated Ringers
Description: 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.
Arm group label: acetated Ringers

Other name: Ringer's acetate

Other name: ringer acetate

Other name: acetate Ringer´s

Intervention type: Drug
Intervention name: albumin 5%
Description: 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.
Arm group label: albumin 5%

Other name: Albumin (Human) 5%

Other name: Human Albumin 5%

Intervention type: Drug
Intervention name: albumin 20%
Description: 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.
Arm group label: albumin 20%

Other name: Human Albumin 20%

Other name: Albumin (Human) 20%

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Vrinnevi Hospital

Address:
City: Norrköping
Zip: 60379
Country: Sweden

Status: Recruiting

Contact:
Last name: Robert Svensson, MD

Phone: +46101040000
Email: robert.svensson@regionostergotland.se

Contact backup:
Last name: Fredrik Schiöler, MD

Phone: +46101040000
Email: fredrik.schioler@regionostergotland.se.se

Investigator:
Last name: Robert Svensson, MD
Email: Principal Investigator

Start date: October 23, 2023

Completion date: October 31, 2025

Lead sponsor:
Agency: Joachim Zdolsek
Agency class: Other

Source: University Hospital, Linkoeping

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05726136