Fluid Challenge and Plasma Volume, During Surgery (FC-VE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Colorectal Cancer; Colorectal Disorders; Urologic Cancer; Benign Neoplasm
• Intervention / Treatment: Drug: acetated Ringers; Drug: albumin 5%; Drug: albumin 20%

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robert Svensson, MD; Phone Number: +4610142305; Email: robert.svensson@regionostergotland.se
• Study Contact Backup: Name: Hans Bahlmann, MD, PhD; Phone Number: +46101031860; Email: hans.bahlmann@regionostergotland.se

Study Locations

• Sweden
  • Östergötland County
    • Norrköping, Östergötland County, Sweden, 60379
      • Recruiting
      • Vrinnevi Hospital
      • Contact: Robert Svensson, MD; Phone Number: +46101040000; Email: robert.svensson@regionostergotland.se
      • Contact: Fredrik Schiöler, MD; Phone Number: +46101040000; Email: fredrik.schioler@regionostergotland.se.se
      • Principal Investigator: Robert Svensson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Ringer's acetate; ringer acetate; acetate Ringer´s
Experimental: 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.	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.; Other Names: Human Albumin 5%; Albumin (Human) 5%
Experimental: 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.	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.; Other Names: Human Albumin 20%; Albumin (Human) 20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma volume expansion after a fluid bolus	Plasma volume using hemoglobin as an indicator of dilution	60 minutes after an intravenous fluid bolus

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Joachim Zdolsek
• Investigators: Principal Investigator: Joachim Zdolsek, MD PhD, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 15, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopic surgery, fluid therapy, plasma volume
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplasms; Colorectal Neoplasms; Urologic Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Albumins; Ringer's acetate; zidovudine 5'-monophosphate-mannose-albumin conjugate; galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20
• Other Study ID Numbers: FC-VE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual de-identified results will be shared, when results are published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No