ファーマシューティカ アナリティカ アクタ

概要

Blood Volume Determination Through New Generation 130/0,4 Hydroxyethyl-Starch: A Propaedeutic, In-Vitro Study

Luca di Girolamo, Giacomo Trevisan, Marco V Resta, Rea Valaperta, Roberto Iorio, Gianluca Spinelli, Federica Ferrari, Fortunata Lombardi, Elena Costa and Marco Dei Poli

Background: The importance of knowing the blood volume, in critically ill patients, collides with the difficulty to have its direct measure through a safe and economic method. Hydroxyethyl starch (HES) was introduced by Tschaikowsky as a useful marker for the dilution method, calculating the HES concentration (HESC) in a solution by inducing an in-vitro hydrolysis of starch molecules into glucose monomers and dosing the consequent increase of the solution glucose level (Δ GLUCOSE). Objective: This study develops a simple and cheap laboratory technique which uses a new generation 6% 130/0,4 Hydroxyethyl starch as a possible “dilution marker” for the measurement of patient’s blood volume maintaining Tschaikowsky’s study protocol. The aim is to refocus attention on an interesting method that could lead the way to a number of possibilities in critical area. Method: We designed a two-phase in-vitro experiment. Firstly, we found out the suitable treatment duration to ensure a complete hydrolysis of starch molecules. Secondly, we aimed to the achievement of a univocal constant of proportionality (K) between Δ GLUCOSE and HES concentration. HESC will be expressed as HESV/PV (μl/mL) where HESV represents the HES volume and PV the plasma volume. Plasma volumes were calculated as BV*(1-Ht). Results: K was planned by means of a linear regression analysis between HESV/PV and Δ GLUCOSE on 133 validated samples collected from 30 healthy volunteers. The obtained hematocrit values ranged between 39.9 and 48 (mean ± CI 95%=42,62 ± 2,93). This corresponded to HESC ranging from 0,033 to 0,038 HES (mL)/PV (mL) (mean ± CI 95%=0,035 ± 0,002). While hydrolysis times increase, glucose values tended to augment until they reached stable plateau. During the second phase we handled a total of 720 specimens. Hematocrit of collected samples ranged from 33,9 to 49 (mean ± CI 95%=41,3 ± 1,21). HESC ranged between 0,015 and 0,089 mL HES/mL PV (mean ± CI 95%=0,037 ± 0,003). The regression analysis showed that HESC equals 0,592 times Δ GLUCOSE (R2=0,947). Conclusion: This study might be the first step in reintroducing starches into the clinical management of critical patients, not just as therapeutic agents for volume resuscitation but even as useful markers in the diagnosis of hemodynamic derangements, improving fluid and blood therapy strategies.