Abstract
Objective. To evaluate the efficiency of using hydroxyethyl starch (HES) 130/0.4 (Voluven 6%) versus physiologic saline (PS) as an initial agent for the therapy of arterial hypotension in the early neonatal period. Subject and methods. A prospective randomized open-label study was conducted from January 2010 to September 2011. The study included all neonates admitted to a neonatal intensive care unit (NICU) regardless of diagnosis and gestational age who were diagnosed with arterial hypotension in the first 24 hours of life. The exclusion criterion was acute bleeding in neonates. In all the neonatal infants enrolled in the trial, the vital parameters were routinely monitored including blood pressure (BP), heart rate, and diuresis. Before and after therapy, the investigators determined blood pH, pCO 2, pO 2 glucose, and lactate, performed echocardiography, and studied regional hemodynamics in the anterior cerebral artery, renal artery, and upper mesenteric artery. HES 130/0.4 (Voluven 6%) and PS were used as a volume-replacement solution. After using the solutions, the examination protocol involved a hemostatic study and biochemical and clinical blood tests. BP normalization time and therapeutic effect duration were also recorded. Case history data were used to estimate the length of a hypotensive episode, the total one- and 7-day dose of cardiotonic agents, and the duration of their use. Results. PS and HES 130/0.4 infusions normalized regional blood flow. What is more, there was a significant rise in diuresis after infusion of both agents. Pre- and postinfusion measurements of pH and lactate levels showed a significant increase in pH after using both solutions. A significant drop in lactate levels to the normal values was recorded only after Voluven 6% infusion; there was no elevation of serum sodium concentrations after use of both agents. No differences were found in liver enzymes and protein C levels and prothrombin index. In-depth analysis revealed that the administration of Voluven 6% in extremely low birth weight babies elevated blood creatinine levels, prolonged activated partial thromboplastin time, and increased the rate of intraventricular hemorrhage. At the same time, the described complications were not characteristic of neonates weighing 1000 g or more. Evaluation of therapeutic effectiveness in relation to birth weight indicated that Voluven had some advantage over PS in decreasing the needs for cardiotonic support only in the patients weighing 1000 g or more. Conclusion. Voluven 6% is more effective than PS in increasing cardiac output (CO), myocardial contractility, daily diuresis, maintaining normal fluid balance, resolving tissue hypoxia (normalizing lactate level), decreasing the need for a subsequent infusion of dopamine, reducing its dose and cardiotonic support time. Voluven may be recommended for the therapy of arterial hypotension in neonatal infants weighing more than 1000 g along with PS particularly in the situations when besides BP normalization, there was a need for promptly and effectively increased CO and normalized microcirculation in shock states.
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