Fluid Challenge and Plasma Volume, During Surgery

NCT ID: NCT05726136

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2025-10-31

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.

Conditions

Colorectal Cancer; Urologic Cancer; Gynecologic Cancer; Colorectal Disorders; Benign Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

acetated Ringers

Intervention Type: DRUG

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%

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.

Group Type: EXPERIMENTAL

albumin 5%

Intervention Type: DRUG

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%

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.

Group Type: EXPERIMENTAL

albumin 20%

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ringer's acetate; ringer acetate; acetate Ringer´s; Albumin (Human) 5%; Human Albumin 5%; Human Albumin 20%; Albumin (Human) 20%

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joachim Zdolsek

OTHER

Sponsor Role: lead

Responsible Party

Joachim Zdolsek

consultant, assoc prof

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joachim Zdolsek, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Locations

Vrinnevi Hospital

Norrköping, Östergötland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Robert Svensson, MD

Role: CONTACT

robert.svensson@regionostergotland.se

+4610142305

Hans Bahlmann, MD, PhD

Role: CONTACT

hans.bahlmann@regionostergotland.se

+46101031860

Facility Contacts

Robert Svensson, MD

Role: primary

robert.svensson@regionostergotland.se

+46101040000

Fredrik Schiöler, MD

Role: backup

fredrik.schioler@regionostergotland.se.se

+46101040000

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FC-VE

Identifier Type: -

Identifier Source: org_study_id