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NCT Number: NCT05726136

Fluid Challenge and Plasma Volume, During 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ringer's acetate, ringer acetate, acetate Ringer´s

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.

Other names: Albumin (Human) 5%, Human 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.

Other names: Human Albumin 20%, Albumin (Human) 20%

Primary outcomes

  1. Plasma volume expansion after a fluid bolus

    Time frame: 60 minutes after an intravenous fluid bolus

    Plasma volume using hemoglobin as an indicator of dilution

Secondary outcomes

  1. Fluid Balance

    Time frame: 18 to 24 hours

    Calculations of fluid balance

  2. Stroke Volume

    Time frame: 60 minutes after an intravenous fluid bolus

    Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))

  3. Arterial Blood Pressure

    Time frame: 60 minutes after an intravenous fluid bolus

    Mean Arterial Pressure, measured with an arterial line.

  4. Heart Rate

    Time frame: 60 minutes after an intravenous fluid bolus

    Heart rate, measured with ECG and pulseoximeter.

  5. Bioimpedance

    Time frame: 18 to 24 hours

    Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.

  6. Serum Creatinin

    Time frame: 18 to 24 hours

    Serum Creatinin as a measure of kidney function

  7. arterial pH

    Time frame: 60 minutes after an intravenous fluid bolus

    Influence of a fluid bolus on arterial blood gases

  8. arterial Base Excess

    Time frame: 60 minutes after an intravenous fluid bolus

    Influence of a fluid bolus on arterial blood gases

  9. arterial serum sodium

    Time frame: 60 minutes after an intravenous fluid bolus

    Influence of a fluid bolus on Sodium concentration

  10. arterial serum chloride

    Time frame: 60 minutes after an intravenous fluid bolus

    Influence of a fluid bolus on Chloride concentrations

Study contacts

Contact information is provided by the study sponsor or research team.

Hans Bahlmann, MD, PhD

CONTACT

[email protected]

+46101031860

Robert Svensson, MD

CONTACT

[email protected]

+4610142305

Sponsors and collaborators

Lead sponsor

Joachim Zdolsek

Other

Registry information

Official study title

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

Acronym: FC-VE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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