Fluid Challenge and Plasma Volume, During Surgery

Colorectal Cancer Clinical Trial

— FC-VE  

Official title:

Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726136
• Other study ID #: FC-VE
• Status: Recruiting
• Phase: Phase 4
• Start date: October 23, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: March 2024
• Source: University Hospital, Linkoeping
• Contact: Robert Svensson, MD
• Phone: +4610142305
• Email: robert.svensson[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Neoplasm
• Colorectal Cancer
• Colorectal Disorders
• Gynecologic Cancer
• Neoplasms
• Urologic Cancer
• Urologic Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Vrinnevi Hospital	Norrköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Joachim Zdolsek

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma volume expansion after a fluid bolus	Plasma volume using hemoglobin as an indicator of dilution	60 minutes after an intravenous fluid bolus
Secondary	Fluid Balance	Calculations of fluid balance	18 to 24 hours
Secondary	Stroke Volume	Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))	60 minutes after an intravenous fluid bolus
Secondary	Arterial Blood Pressure	Mean Arterial Pressure, measured with an arterial line.	60 minutes after an intravenous fluid bolus
Secondary	Heart Rate	Heart rate, measured with ECG and pulseoximeter.	60 minutes after an intravenous fluid bolus
Secondary	Bioimpedance	Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.	18 to 24 hours
Secondary	Serum Creatinin	Serum Creatinin as a measure of kidney function	18 to 24 hours
Secondary	arterial pH	Influence of a fluid bolus on arterial blood gases	60 minutes after an intravenous fluid bolus
Secondary	arterial Base Excess	Influence of a fluid bolus on arterial blood gases	60 minutes after an intravenous fluid bolus
Secondary	arterial serum sodium	Influence of a fluid bolus on Sodium concentration	60 minutes after an intravenous fluid bolus
Secondary	arterial serum chloride	Influence of a fluid bolus on Chloride concentrations	60 minutes after an intravenous fluid bolus