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Impact of Hyperoncotic Albumin to Support Blood Loss Replacement

Impact of Hyperoncotic Albumin to Support Blood Loss Replacement on Plasma Volume Expansion in Cystectomy Patients.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03848507
Acronym
HYPALB
Enrollment
24
Registered
2019-02-20
Start date
2019-03-18
Completion date
2020-02-18
Last updated
2020-02-20

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

Conditions

Blood Loss, Surgical, Fluid Retention

Keywords

hyperoncotic albumin, blood loss, fluid replacement, cystectomy

Brief summary

Fluid treatment is usually performed with either balanced crystalloid fluids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids (impairment of renal function and coagulation), and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution (endogenous fluid recruitment). The primary objective of this study is to test the effect of 20% albumin on plasma volume expansion and fluid recruitment in the frame of blood loss replacement during cystectomy using established fluid kinetic models. The investigators expect that fluid replacement with crystalloid will be better sustained intravascularly with the administration of 20% albumin and be able to recruit fluid into the vascular compartment.

Detailed description

Bladder cancer occurs mainly in old comorbid patients. The standard treatment of localized muscle invasive bladder cancer is pelvic lymph node dissection and open radical cystectomy with urinary diversion. Optimal perioperative fluid management for this surgery is challenging and still controversial in terms of how much to perfuse, choice of fluids (crystalloids and colloids) to restore hydrated state and volemia. Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic synthetic colloids, plasma or 5% albumin. Because crystalloids quickly equilibrate between the intravascular and interstitial volumes, they are mainly used to treat dehydration and temporary volume deficits. Iso-oncotic colloids remain intravascular for a prolonged period. Doubts have been raised about synthetic colloids, and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution (endogenous fluid recruitment). There are still unknown aspects of the physiological effects of hyper-oncotic albumin. One of them is the, in this study investigated, effect of 20% albumin on plasma volume expansion, fluid recruitment, and crystalloid kinetic in the frame of blood loss replacement during cystectomy. It is expected that fluid replacement with crystalloid will be better sustained intravascularly with the administration of 20% albumin.

Interventions

Intravenous administration of 20% albumin during cystectomy

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Non emergent radical cystectomy with urinary diversion * Adult: older than 18 years * Written informed consent

Exclusion criteria

* Significant renal dysfunction: glomerular filtration rate \< 60 ml/min/1,73 m² (Kidney Disease Outcomes Quality Initiative stage 3 or more ) * History of heart failure * Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, * Women who are pregnant or breast feeding (exclusion of surgery per se) * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Enrolment of the investigator, his/her family members, employees and other dependent persons

Design outcomes

Primary

MeasureTime frameDescription
Plasma volume expansion5 hoursCalculated by kinetics models

Secondary

MeasureTime frameDescription
Colloid osmotic pressure5 hoursMeasured by oncometer
Fluid balance24 hoursComposite score calculated according to fluid administered (crystalloid, colloids, blood products) and fluid loss (urine and blood)
Complications rate90 daysAssessment of all complications occurring from postoperative day 1 to 90 according to the Clavien Dindo classification

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026