Fluid Challenge and Plasma Volume, During Surgery

Sponsor
Joachim Zdolsek
Study ID
NCT05726136
Phase
PHASE4
Status
Recruiting
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Conditions

  • Benign Neoplasm
  • Colorectal Cancer
  • Colorectal Disorders
  • Gynecologic Cancer
  • Urologic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Feb 13, 2023
Start date
Oct 23, 2023
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Plasma volume expansion after a fluid bolus [ Time Frame: 60 minutes after an intravenous fluid bolus ]

Central Contacts

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