Rheo-STAT project. New options of the intoxication syndrome therapy from the point of view of the evidence: accent on pneumonia

Abstract

Background. Pneumonia is a widespread disease and an often cause of hospitalizations both in Vietnam and Georgia. The supportive treatment of pneumonias includes the respiratory support, the support of fluid and electrolyte balance, parenteral nutrition and some additional drugs (analgesics, corticosteroids, inotropes). Rheo-STAT study is an interventional open-label randomized controlled study of Reosorbilact (“Yuria-Pharm”) effectiveness in pneumonia treatment. The study was held in 7 countries (Ukraine, Moldova, Georgia, Vietnam, Kazakhstan, Kyrgyzstan, Uzbekistan).
 Objective. To assess Reosorbilact effectiveness in the elimination of the intoxication syndrome.
 Materials and methods. 628 adult patients with sepsis, peritonitis, pneumonias and burns took part in this study. The pneumonia subgroup included 150 people (62 % males, mean age – 41.3 years, 33 % had some concomitant diseases). Inclusion criteria were the following: age – 18-60 years, community-acquired pneumonia and antibiotic therapy, administered not later than after 48 hours after the disease beginning, at least IV class according to PSI/PORT index, the presence of informed consent, baseline level of SOFA points ≥2. The assessment according to the SOFA scale on the 3rd day of treatment in comparison to the baseline level was the primary endpoint. Secondary endpoints included the change of mean result according to other scales (APACHE II, SAPS II, MODS, PSI/PORT, CURB-65) and changes of biochemical, immunological and integral markers of endogenous intoxication.
 Results and discussion. Infusion therapy with the help of Reosorbilact (200-400 ml per day) led to the increase of circulating blood volume and to the decrease of total infusion volume without any risk of volume overload. Lactate – one of the Reosorbilact components – did not increase the endogenous lactate level, which testifies a high safety. Inclusion of Reosorbilact into the combined treatment in 3 days led to the body temperature decrease from 39.37 to 36.77 °С, heart rate decrease from 105.27 to 77.81 bpm, leucocytes amount – from 9.38 to 6.64×109/L. Blood oxygenation also increased at the 3rd day of treatment, and PSI/PORT index decreased from 101.47 to 49.07. Pulmonary edema or pleural effusion were not revealed in any patients.
 Conclusions. 1. Pneumonia is a widespread disease, which often requires hospitalization. 2. Infusion therapy with the help of Reosorbilact increases the circulating blood volume without a risk of volume overload. 3. Inclusion of Reosorbilact into the combined treatment of pneumonia in 3 days leads to the decrease of body temperature, heart rate, leucocyte amount and to the increase of blood oxigenation.