Actively Recruiting

Phase 4
Age: 18Years - 85Years
All Genders
ID05726136

Comparison of Albumin and Ringer's Solution for Optimizing Plasma Volume and Hemodynamics During Laparoscopic Surgery

Led by Joachim Zdolsek · Updated on 2026-04-30

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the plasma expanding effects of three different fluid challenge strategies during longer laparoscopic abdominal surgeries lasting over 90 minutes. The study includes 60 patients randomized into three groups to compare acetated Ringers, albumin 5%, and albumin 20% solutions. The goal is to understand how these fluid treatments affect blood volume and circulation using hemoglobin as an indicator. The study groups receive specific fluid boluses: acetated Ringers at 4 ml/kg body weight, albumin 5% at 4 ml/kg, and albumin 20% at 1 ml/kg. After the first bolus infusion during surgery, if cardiac output increases by 10%, a second bolus is given and further studied. Circulatory effects are monitored using a Cardio Q probe inserted into the esophagus, and blood samples are taken at several intervals before and after fluid infusions. Participants undergo various assessments including blood tests for hemoglobin, albumin, and colloid osmotic pressure before surgery and at multiple time points during surgery. Additional measurements include bioimpedance, urine osmolality, and arterial blood gases. Researchers measure plasma volume expansion as the primary outcome at 60 minutes after fluid bolus, along with secondary measures like stroke volume, blood pressure, heart rate, and biochemical markers. The study is expected to conclude by October 2026.

CONDITIONS

Brief Title

Fluid Challenge and Plasma Volume, During Surgery

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written consent to participate in the study
  • For women: use of relevant contraception, menopausal status, or a negative pregnancy test
  • ASA category I to III
  • Scheduled for laparoscopic abdominal surgery lasting at least 90 minutes
  • Age between 18 and 85 years
Not Eligible

You will not qualify if you...

  • Known cardiac failure
  • Age under 18 or over 85 years
  • Known allergy to albumin
  • Extracellular hyperhydration or hypervolemia
  • Kidney failure
  • Pregnancy or planned pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery lasting at least 90 minutes

Participants receive a fluid bolus of acetated Ringers, albumin 5%, or albumin 20% during laparoscopic abdominal surgery. Circulatory and plasma volume effects are studied with blood samples and other measurements taken before and after fluid infusions.

1 visit (in-person, during surgery)

Follow-up

Duration - 18 to 24 hours after surgery

Participants are monitored for fluid balance, bioimpedance, kidney function, and circulatory parameters up to 24 hours after surgery.

1 to 2 visits depending on assessments

Trial Site Locations

Total: 1 location

1

Vrinnevi Hospital

Norrköping, Östergötland County, Sweden, 60379

Actively Recruiting

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Research Team

R

Robert Svensson, MD

H

Hans Bahlmann, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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