Impact of Hyperoncotic Albumin to Support Blood Loss Replacement

Blood Loss, Surgical Clinical Trial

— HYPALB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848507
• Other study ID #: HYPALB
• Status: Completed
• Phase: Phase 4
• Start date: March 18, 2019
• Est. completion date: February 18, 2020

Study information

• Verified date: February 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 18, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Fluid Retention
• Hemorrhage

Intervention

Drug:
• albumin 20%
Intravenous administration of 20% albumin during cystectomy

Locations

Country	Name	City	State
Switzerland	Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma volume expansion	Calculated by kinetics models	5 hours
Secondary	Colloid osmotic pressure	Measured by oncometer	5 hours
Secondary	Fluid balance	Composite score calculated according to fluid administered (crystalloid, colloids, blood products) and fluid loss (urine and blood)	24 hours
Secondary	Complications rate	Assessment of all complications occurring from postoperative day 1 to 90 according to the Clavien Dindo classification	90 days