Clinical trial NCT05391607: Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement
Official title: Randomized Trial of Intraoperative Intravascular Effect of Hyper-oncotic 20% Albumin, Iso-oncotic 5% Albumin and Ringer Lactate During Haemorrhage in Cystectomy. A Prospective Randomized Active-controlled Single Centre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss, Surgical
Fluid Retention
Keywords: hyperoncotic
isooncotic
albumin 20%
albumin 5%
ringer lactate
blood loss
hemorrhage
fluid replacement
intravascular effect
volume expansion
cystectomy
pro-ANP
pro-BNP
glycocalyx proteins
microcirculation damages
endothelial shedding
CD138/syndecan 1
heparan sulfate
hyaluronic acid
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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 to restore hydrated state and volemia.

Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic synthetic colloids, or albumin 5%. Because crystalloids quickly equilibrate between the intravascular and interstitial volumes, they are mainly used to treat dehydration and temporary volume deficits. 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.

Iso-oncotic colloids (Albumine 5%) remain intravascular for a prolonged period, but they play a neutral role in terms of endogenous fluid recruitment, as the oncotic pressure is equilibrated between the intra- and extra- vascular territories.

An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the albumin 20% solution, which has showed the advantage in its blood volume expansion capacities over crystalloids (endogenous fluid recruitment).

The effects of the Albumin 20% solution have until now never been compared in a same perioperative setting to the Albumin 5% nor to Ringer-lactate solution.

The investigators will evaluate the physiological effects and their outcomes between these fluid therapies in the frame of blood loss replacement during the hemorrhagic part of cystectomy procedures. The investigators will as well assess the variation of hemodynamic parameters (pro-ANP, pro-BNP) and the resulting microcirculation damages (endothelial wall shedding).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Contraindications to the class of drugs under study (i.e: known hypersensitivity/ allergy to class of drugs or to the investigational product).
* Renal insufficiency: GFR: \<60ml/min/1.73m2 (KDIGO Clinical Practice Guideline for Acute Kidney Injury, stage 3 and over).
* History of heart failure.
* Use of diuretic treatment.
* 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.

Primary outcomes:
measure: Plasma volume expansion
timeFrame: 5 hours
Secondary outcomes:
measure: Biological markers (pro-ANP and pro-BNP)
timeFrame: 24 hours
measure: Cardiac output (CO)
timeFrame: 5 hours
measure: Endothelial damage
timeFrame: 24 hours
measure: Stroke volume (SV)
timeFrame: 5 hours
measure: Pleth variability index (PVI)
timeFrame: 5 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
state: BE
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Patrick Y Wuethrich, MD
role: PRINCIPAL_INVESTIGATOR
References: