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Impact of Hyperoncotic Albumin to Support Blood Loss Replacement (HYPALB)

Primary Purpose

Blood Loss, Surgical, Fluid Retention

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
albumin 20%
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical focused on measuring hyperoncotic albumin, blood loss, fluid replacement, cystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

20% Albumin

Arm Description

Administration of 3ml per kg bodyweight of 20% albumin within 30 min during cystectomy.

Outcomes

Primary Outcome Measures

Plasma volume expansion
Calculated by kinetics models

Secondary Outcome Measures

Colloid osmotic pressure
Measured by oncometer
Fluid balance
Composite score calculated according to fluid administered (crystalloid, colloids, blood products) and fluid loss (urine and blood)
Complications rate
Assessment of all complications occurring from postoperative day 1 to 90 according to the Clavien Dindo classification

Full Information

First Posted
February 19, 2019
Last Updated
February 18, 2020
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03848507
Brief Title
Impact of Hyperoncotic Albumin to Support Blood Loss Replacement
Acronym
HYPALB
Official Title
Impact of Hyperoncotic Albumin to Support Blood Loss Replacement on Plasma Volume Expansion in Cystectomy Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Fluid Retention
Keywords
hyperoncotic albumin, blood loss, fluid replacement, cystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20% Albumin
Arm Type
Experimental
Arm Description
Administration of 3ml per kg bodyweight of 20% albumin within 30 min during cystectomy.
Intervention Type
Drug
Intervention Name(s)
albumin 20%
Intervention Description
Intravenous administration of 20% albumin during cystectomy
Primary Outcome Measure Information:
Title
Plasma volume expansion
Description
Calculated by kinetics models
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Colloid osmotic pressure
Description
Measured by oncometer
Time Frame
5 hours
Title
Fluid balance
Description
Composite score calculated according to fluid administered (crystalloid, colloids, blood products) and fluid loss (urine and blood)
Time Frame
24 hours
Title
Complications rate
Description
Assessment of all complications occurring from postoperative day 1 to 90 according to the Clavien Dindo classification
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Wuethrich, MD
Organizational Affiliation
Inselspital Bern Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
City
Bern
State/Province
BE
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33957864
Citation
Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.
Results Reference
derived
PubMed Identifier
32947291
Citation
Loffel LM, Hahn RG, Engel D, Wuethrich PY. Intraoperative Intravascular Effect of Lactated Ringer's Solution and Hyperoncotic Albumin During Hemorrhage in Cystectomy Patients. Anesth Analg. 2021 Aug 1;133(2):413-422. doi: 10.1213/ANE.0000000000005173.
Results Reference
derived

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Impact of Hyperoncotic Albumin to Support Blood Loss Replacement

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