NCT05726136 Fluid Challenge and Plasma Volume, During Surgery
| NCT ID | NCT05726136 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Joachim Zdolsek |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2023-10-23 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Joachim Zdolsek, MD PhD
PRINCIPAL INVESTIGATOR
Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
Frequently Asked Questions
Who can join the NCT05726136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05726136 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05726136 currently recruiting?
Yes, NCT05726136 is actively recruiting participants. Contact the research team at robert.svensson@regionostergotland.se for enrollment information.
Where is the NCT05726136 trial being conducted?
This trial is being conducted at Norrköping, Sweden.
Who is sponsoring the NCT05726136 clinical trial?
NCT05726136 is sponsored by Joachim Zdolsek. The principal investigator is Joachim Zdolsek, MD PhD at Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. The trial plans to enroll 60 participants.
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