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Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement

NCT05391607 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-04-13

No results posted yet for this study

Summary

Fluid intravascular replacement is usually performed with either balanced crystalloids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids, and albumin solutions have been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. The mobilization of extravascular fluid by infusing a hyper-oncotic solution like 20% albumin solution has been shown, causing endogenous fluid recruitment and blood volume expansion.

The primary objective of this study is to compare the effect on plasma volume expansion and fluid recruitment of 3 different types of fluids (Albumin 5% and Albumin 20% and Ringer-lactate) during the hemorrhagic phase of the cystectomy procedure.

Secondary objectives are the assessment of the hemodynamic parameters during surgery and the follow-up of pro-ANP and pro-BNP peptides. Glycocalyx proteins will be followed to evaluate endothelial wall shedding and microcirculation damages.

Conditions

  • Blood Loss, Surgical
  • Fluid Retention

Interventions

DRUG

Hyperoncotic Albumin 20%

Intravenous administration during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

DRUG

Isooncotic Albumin 5%

Intravenous administration of Albumin 5% 12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

DRUG

Ringer's Lactate Crystalloid Solutions (control group)

Intravenous administration of Ringer-lactate ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Patrick Y Wuethrich, MD · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2023-03-30
Completion
2023-04-10

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391607 on ClinicalTrials.gov