Evaluating fluid strategies during laparoscopic surgery
Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
This study is testing which type of fluid given during long laparoscopic surgeries helps keep patients' blood volume stable.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Linkoeping Academic / other |
| Locations | 1 site (Norrköping, Östergötland County) |
| Trial ID | NCT05726136 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of different fluid challenge strategies on plasma volume during laparoscopic abdominal surgeries lasting over 90 minutes. A total of 60 patients will be randomized into three groups, each receiving a specific fluid type: acetated Ringers, albumin 5%, or albumin 20%. Various blood samples and measurements will be taken before and after fluid administration to assess changes in hemoglobin, albumin, and colloid osmotic pressure. The goal is to determine the most effective fluid strategy for maintaining blood volume during surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 scheduled for laparoscopic abdominal surgery lasting at least 90 minutes.
Not a fit: Patients with known cardiac failure, kidney failure, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve fluid management during surgery, potentially leading to better patient outcomes and recovery.
How similar studies have performed: Previous studies have explored fluid management in surgical settings, but this specific comparison of fluid types is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Norrköping, Östergötland County
- Vrinnevi Hospital — Norrköping, Östergötland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Joachim Zdolsek, MD PhD — Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
- Study coordinator: Robert Svensson, MD
- Email: robert.svensson@regionostergotland.se
- Phone: +4610142305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.