Own experience in an open multicenter randomized controlled trial Rheo-STAT on the efficacy and safety of Reosorbilact in patients with peritonitis in Moldova

Abstract

Background. Peritonitis is a consequence of complications of the abdominal cavity organs’ diseases (inflammation, injury) and systemic inflammatory reaction of the organism, which is manifested by symptoms of intoxication and dysfunction of all the organs. In case of diffuse peritonitis mortality is about 80 %. Prerequisites of the lethal outcomes include a late visit to the doctor, elderly age, the presence of cancer and diabetes, antibiotic resistance of the pathogen, diagnostic errors. In the department of purulent gynecology peritonitis most often accompanies endometritis, purulent salpingitis, pyosalpinx, abscesses, uterine perforation during curettage. In Moldova, the principles of treatment of peritonitis include the urgent surgery to remove the infection source, aspiration of exudate, massive lavage, abdominal drainage, antibiotic therapy, and correction of metabolic disorders. Objective. To determine the effectiveness of Reosorbilact in eliminating the intoxication syndrome in peritonitis. Materials and methods. The Rheo-STAT study was an international multicenter, randomized, open-label clinical trial of the efficacy and safety of Reosorbilact (“Yuria-Pharm”) in the treatment of sepsis, peritonitis, community-acquired pneumonia, and burn disease. The study was conducted in 7 countries (Ukraine, Moldova, Georgia, Vietnam, Kazakhstan, Kyrgyzstan, Uzbekistan). 5 of them (Ukraine, Moldova, Georgia, Kazakhstan, Uzbekistan) took part in the sub-study Rheo-STAT Peritonitis. The study involved 628 adult patients with sepsis, peritonitis, pneumonia and burns. The subgroup of peritonitis consisted of 180 people (27 % males, 73 % females; mean age – 37 years; concomitant infectious diseases were observed in 25 %, complicated appendicitis – in 17 %), 117 of them were treated in Moldova (87 % females, 13 % males, mean age – 45.2 years). The inclusion criteria were age 18-60 years, diagnosis of peritonitis, the first hours of the postoperative period, no later than 24 hours from diagnosis to the first visit of the study, obtaining informed consent, baseline level on the SOFA scale ≥2. The total score on the SOFA scale on day 3 of treatment compared to baseline was considered a primary endpoint. Secondary endpoints were the change in the overall score on the APACHE II, SAPS II, MODS, PSI/PORT, CURB-65 scales; changes in biochemical, immunological and integral markers of endogenous intoxication. Results and discussion. Low-volume infusion therapy with Reosorbilact (200-400 ml per day) resulted in an increase in circulating blood volume and a decrease in the total volume of infusions required without the risk of volume overload. Exogenous lactate in Reosorbilact did not increase the content of endogenous lactate, which indicates the high safety of the drug. The inclusion of Reosorbilact in the comprehensive treatment after 3 days provided a decrease in body temperature from 37.1 to 36.75 °C, heart rate – from 88.5 to 82.0 bpm, the leukocyte count – from 11.0 to 7.2×109/L. Reosorbilact therapy in 3 days improved the acid-base balance, as evidenced by the increase in the base excess from -2.73 to -0.57 mmol/L and an increase in standard bicarbonate from 21.8 to 23.5 mmol/L. Conclusions. 1. Prerequisites for the lethal consequences of peritonitis include a late visit to the doctor, elderly age, the presence of cancer and diabetes, antibiotic resistance of the pathogen, and diagnostic errors. 2. Elimination of intoxication syndrome is one of the main components of peritonitis treatment. 3. Reosorbilact infusion therapy increases the volume of circulating blood without the risk of volume overload. 4. The inclusion of Reosorbilact into the comprehensive treatment of sepsis after 3 days provided a decrease in body temperature, heart rate, white blood cell count and normalization of the acid-base composition of the blood.