NCT03848507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

February 19, 2019

Last Update Submit

February 18, 2020

Conditions

Blood Loss, SurgicalFluid Retention

Keywords

hyperoncotic albumin, blood loss, fluid replacement, cystectomy

Outcome Measures

Primary Outcomes (1)

  • Plasma volume expansion

    Calculated by kinetics models

    5 hours

Secondary Outcomes (3)

  • Colloid osmotic pressure

    5 hours

  • Fluid balance

    24 hours

  • Complications rate

    90 days

Study Arms (1)

20% Albumin

EXPERIMENTAL

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

Drug: albumin 20%

Interventions

albumin 20%DRUG

Intravenous administration of 20% albumin during cystectomy

20% Albumin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 33957864DERIVED

  • 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.

    PMID: 32947291DERIVED

MeSH Terms

Conditions

Blood Loss, SurgicalHemorrhage

Interventions

galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Patrick Wuethrich, MD

    Inselspital Bern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 20, 2019

Study Start

March 18, 2019

Primary Completion

February 12, 2020

Study Completion

February 18, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)