Influence of hyperoncotic 20% albumin, iso-oncotic 5% albumin, and Ringer's lactate on plasma volume expansion in hemorrhage during cystectomy. A prospective, randomized, controlled monocentric study. (VASCALB)

Résumé de l'étude

Bladder removal with urinary diversion is a major urological surgery during which blood loss may occur. To correct this, various infusion therapies are available. Often, so-called crystalloid infusion solutions, i.e., aqueous infusion solutions with dissolved salts, are used. However, these only remain in the bloodstream for a limited time before being either transferred to the tissue or excreted. Hyperoncotic solutions, such as 20% albumin, are also used. This means that it is an infusion solution in which, due to the increased proportion of dissolved protein, the binding or retention of free water in the bloodstream is increased. In healthy subjects, it has been shown that an infusion of this solution significantly increases blood plasma volume by mobilizing fluid from the tissue, and that this effect lasts for several hours. There is also an infusion solution, 5% albumin, which is referred to as iso-oncotic. This means that it is in equilibrium with the amount of protein also found in human plasma. We now want to investigate how strongly this effect can be demonstrated in the replacement of blood loss. We investigate how much blood volume increases when administering 3 ml/kg body weight of the 20% albumin solution or 12 ml/kg body weight of the 5% albumin solution and compare the results with a third group receiving crystalloid (saline) Ringer's lactate infusion solution.

(BASEC)

Intervention étudiée

With this study, we want to compare the influence of using an infusion solution for the replacement of blood loss during bladder removal on blood volume increase. The three infusion solutions are hyperoncotic albumin 20%, normo-oncotic albumin 5%, and the current so-called physiological solution, which has no oncotic effect. The aim of this study is to investigate and compare the effects of different fluid replacement therapies (hyperoncotic 20% albumin, iso-oncotic 5% albumin, and Ringer's lactate) during the hemorrhagic phase of the cystectomy procedure. The fluids will be administered using established fluid kinetics models, and their effect on volume and intravascular filling will be evaluated. We will assess hemodynamic parameters during the operation and evaluate other important biological parameters through blood samples. Complications occurring during the hospitalization period and within the first 30 days after surgery will also be analyzed.

(BASEC)

Maladie en cours d'investigation

Bladder cancer primarily occurs in older, polymorbid patients. The standard treatment for localized, muscle-invasive bladder cancer is cystectomy (bladder removal). Bladder removal with urinary diversion is a major urological surgery during which blood loss may occur. Intraoperatively, systemic inflammatory reactions are triggered by the procedure. The normal regulation of transcapillary fluid exchange is thereby disturbed. Additionally, hypovolemia is exacerbated by blood loss. Therefore, it is essential to replace this volume loss with the most efficient exogenous fluid supply.

(BASEC)

Sponsor

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique de Berne

(BASEC)

Date d'approbation du comité d'éthique

11.05.2022

(BASEC)

Résultats de l'essai