Does a fluid bolus intravenously expand the plasma volume?

Comparison of albumin and Ringer´s solution for optimization of the plasma volume and hemodynamics during surgery. - Fluid challenge and plasma volume

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000861-34-SE

Enrollment

Registered

2021-12-15

Start date

2022-07-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients in need of major laparoscopic surgery in the abdomen, lasting longer than 90 minutes

Interventions

Trade Name: Alburex 50 g/l Product Name: Human albumin Pharmaceutical Form: Solution for infusion INN or Proposed INN: Albumin Other descriptive name: HUMAN ALBUMIN SOLUTION Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject scheduled for major laparoscopic bowel surgery lasting 90 minutes or more. Research subject giving written approval Non-pregnant female subject adequate contraceptive, negative pregnancy test or menopausal/without bleeding the last year) Subjects belonging to ASA-classifications I to III 18 to 80 years of age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Patient with known congestive heart failure 80 years of age Known allergic reaction to albumin Pronounced Kidney failure Pregnancy, breast feeding or planned pregnancy Mental incapability, sight or language problems, influencing the capability to understand the implications of participating in the study. Recent paticipation in a clinical trial the last 30 days. Earlier participation in the current study.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Changes in cardiac output, blood pressure and pulse as well as measurements in plasma of albumine and kreatinin. Fluidcomposition and balance preoperative and one day after surgery.;Timepoint(s) of evaluation of this end point: Preoperative, after surgery and at the first postoperative day	—

Primary

Measure	Time frame
Main Objective: Does a fluid challenge give an increase in plasmavolume, measured as a dilution of the red blood cells, during bariatric surgery? Does acetated Ringers give a similar plasmavolume increase as albumin solutions both in size and in length?;Secondary Objective: Is there a correlation between volume effect and circulatory effects, such as blood pressure and cardiac output? Does "fluid challenge" with acetated Ringers resilt in a clinical relevant effect (plasma volume and cardiac output) on the longer run? In the perspective of 24 hours, does the choise of fluid have any importance for the fluid balance of the body? How are kidney function markers and arterial blood gases influenced by the three different fluid therapies?;Primary end point(s): Decrease of hemoglobine concentration when a fluid challenge is adminstered. The decrease is processed mathematically in a kinetic model.;Timepoint(s) of evaluation of this end point: Before, during and up to 60 minutes after the fluid challenge. Timepoints to be statiscaly evaluated are before and after the infusion as well as 30 minutes after end of the infusion.	—

Measure

Time frame

Main Objective: Does a fluid challenge give an increase in plasmavolume, measured as a dilution of the red blood cells, during bariatric surgery? Does acetated Ringers give a similar plasmavolume increase as albumin solutions both in size and in length?;Secondary Objective: Is there a correlation between volume effect and circulatory effects, such as blood pressure and cardiac output? Does "fluid challenge" with acetated Ringers resilt in a clinical relevant effect (plasma volume and cardiac output) on the longer run? In the perspective of 24 hours, does the choise of fluid have any importance for the fluid balance of the body? How are kidney function markers and arterial blood gases influenced by the three different fluid therapies?;Primary end point(s): Decrease of hemoglobine concentration when a fluid challenge is adminstered. The decrease is processed mathematically in a kinetic model.;Timepoint(s) of evaluation of this end point: Before, during and up to 60 minutes after the fluid challenge. Timepoints to be statiscaly evaluated are before and after the infusion as well as 30 minutes after end of the infusion.

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Countries

Sweden

Contacts

Public ContactRegion Ostergotland

Region Ostergotland

46101030000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026