Does a fluid bolus intravenously expand the plasma volume?

Phase 1

• Conditions: Patients in need of major laparoscopic surgery in the abdomen, lasting longer than 90 minutes; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2021-000861-34-SE
• Lead Sponsor: Region Ostergotland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Patient with known congestive heart failure
<18 years or >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified