Status:

COMPLETED

Impact of Hyperoncotic Albumin to Support Blood Loss Replacement

Lead Sponsor:

Insel Gruppe AG, University Hospital Bern

Conditions:

Blood Loss, Surgical

Fluid Retention

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 (imp...

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 diver...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

March 18 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 18 2020

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT03848507

Start Date

March 18 2019

End Date

February 18 2020

Last Update

February 20 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

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

Bern, Canton of Bern, Switzerland, 3010