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Completed

NCT Number: NCT05391607

Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bern, Canton of Bern, 3010, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperoncotic Albumin 20%

Drug

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

Other names: Albumin 20%

Isooncotic Albumin 5%

Drug

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.

Other names: Albumin 5%

Ringer's Lactate Crystalloid Solutions (control group)

Drug

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.

Other names: Ringer Lactate

Primary outcomes

  1. Plasma volume expansion

    Time frame: 5 hours

    Difference in plasma volume expansion of albumin 20%, albumin 5% and Ringer lactate calculated by volume kinetics

Secondary outcomes

  1. Biological markers (pro-ANP and pro-BNP)

    Time frame: 24 hours

    Variation and comparison of kinetics hemodynamics biological markers such as pro-ANP and pro-BNP

  2. Cardiac output (CO)

    Time frame: 5 hours

    Evolution of cardiac output (CO) at the start of surgery, begin of infusion, stop of infusion and end of surgery.

  3. Endothelial damage

    Time frame: 24 hours

    Assessment of microcirculation damage due to peroperative stress and fluid therapy through Glycocalyx proteins (CD-138/syndecan 1, heparan sulfate and hyaluronic acid).

  4. Stroke volume (SV)

    Time frame: 5 hours

    Evolution of stroke volume at the start of surgery, begin of infusion, stop of infusion and end of surgery.

  5. Pleth variability index (PVI)

    Time frame: 5 hours

    Evolution of pleth variability index (PVI) at the start of surgery, begin of infusion, stop of infusion and end of surgery.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Acronym: VASCALB

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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