Fluid Challenge and Plasma Volume, During Surgery

NCT05726136 | Recruiting Phase 4 DMC

• 1 other identifier: FC-VE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

laparoscopic surgery, fluid therapy, plasma volume

Outcome Measures

Primary Outcomes (1)

• Plasma volume expansion after a fluid bolus

  Plasma volume using hemoglobin as an indicator of dilution

  60 minutes after an intravenous fluid bolus

Secondary Outcomes (10)

• Fluid Balance

  18 to 24 hours

• Stroke Volume

  60 minutes after an intravenous fluid bolus

• Arterial Blood Pressure

  60 minutes after an intravenous fluid bolus

• Heart Rate

  60 minutes after an intravenous fluid bolus

• Bioimpedance

  18 to 24 hours

Study Arms (3)

acetated Ringers

EXPERIMENTAL

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

albumin 5%

EXPERIMENTAL

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%

albumin 20%

EXPERIMENTAL

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%

Interventions

acetated Ringers 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.

Also known as: Ringer's acetate, ringer acetate, acetate Ringer´s

acetated Ringers

albumin 5% 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.

Also known as: Albumin (Human) 5%, Human Albumin 5%

albumin 5%

albumin 20% 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.

Also known as: Human Albumin 20%, Albumin (Human) 20%

albumin 20%

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• to 85 years

You may not qualify if:

• Patients with known cardiac failure
• \<18 or \>85 years
• known allergy to albumin
• extracellular hyperhydration or hypervolemia
• kidney failure
• pregnancy or planned pregnancy

Sponsors & Collaborators

• Joachim Zdolsek: lead

Study Sites (1)

Vrinnevi Hospital

Norrköping, Östergötland County, 60379, Sweden

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Urologic Neoplasms; Neoplasms

Interventions

Ringer's acetate; zidovudine 5'-monophosphate-mannose-albumin conjugate; Albumins; galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Joachim Zdolsek, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Svensson, MD

CONTACT

+4610142305; robert.svensson@regionostergotland.se

Hans Bahlmann, MD, PhD

CONTACT

+46101031860; hans.bahlmann@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultant, assoc prof

Model Details: 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%

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 13, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)