The first data on international multicenter clinical study RheoSTAT-CP0620 on the efficacy and safety of Rheosorbilact® infusion in therapy of sepsis

  • V.Kh. Sharipova Republican Scientific Center of Emergency Medical Aid, Tashkent, Uzbekistan https://orcid.org/0000-0003-2517-1183
  • S. Beridze JSC EVEX Medical Corporation / Batumi State University named after Shota Rustaveli, Georgia https://orcid.org/0000-0001-7973-1153
  • O.O. Pidmurniak Vinnytsia National Medical University named after М.І. Pyrogov / Khmelnytskyi Regional Hospital, Ukraine https://orcid.org/0000-0003-4356-5100
  • N.A. Shanazarov Medical Centre Hospital of President’s Affairs Administration of the Republic of Kazakhstan, Nur-Sultan, Kazakhstan https://orcid.org/0000-0002-2976-259X
  • Yu.Yu. Kobeliatskyi Dnipro State Medical University, Dnipro, Ukraine
  • V.І. Koshlya SI “Zaporizhzhia Medical Academy of Post-Graduate Education of the Ministry of Health of Ukraine”, Zaporizhzhia, Ukraine
  • S.B. Peev SI “Institute of General and Urgent Surgery named after V.T. Zaitsev of the National Academy of Medical Sciences of Ukraine”, Kharkiv, Ukraine https://orcid.org/0000-0003-0939-9073
  • N. Babunashvili JSC EVEX/LTD – Kutaisi Emergency Referral Hospital, Kutaisi, Georgia
  • V. Cojocaru Republican Clinical Hospital, Chisinau, Moldova https://orcid.org/0000-0001-7220-4107
  • A. Bely Institute of Ambulance, Chisinau, Moldova
  • O.Ye. Kanikovskyi Vinnytsia National Medical University named after М.І. Pyrogov, Vinnytsia, Ukraine
  • I. Pyrtsak Municipal Clinical Hospital “Sfanta Treime”, Chisinau, Moldova
DOI: https://doi.org/10.32902/2663-0338-2022-2-11-20

Abstract

Sepsis stays a common and life-threatening pathological condition; hospital mortality in patients with sepsis exceeds 30 %. Fluid resuscitation is an important component of sepsis treatment. The purpose of this work was to evaluate the efficacy and safety of the multicomponent infusion solution Rheosorbilact in the treatment of patients with sepsis. The international multicenter randomized study RheoSTAT-CP0620 included 180 patients aged 18 to 60 years diagnosed with sepsis. Patients received Rheosorbilact therapy in dosage according to the package insert. A change in the SOFA score on day 3 of treatment was considered to be the primary endpoint. Changes in APACHE II, SAPS II, and MODS scores, as well as changes in endogenous intoxication markers on day 3 of treatment, were considered the secondary endpoints. The safety of the drug was assessed by analysis of adverse events and vital signs after 3 days of therapy. On day 3 of Rheosorbilact treatment, statistically significant changes in SOFA (by 2.01±1.37 points), APACHE II (by 4.24±3.76 points), SAPS II (by 3.40±5.30 points), and MODS (by 1.37±1.37 points) scales were recorded. In addition, there was a statistically significant improvement in markers of endogenous intoxication (urea, creatinine and total bilirubin concentrations, leukocyte counts, and calculated intoxication indices) on day 3 of treatment. The majority of adverse events (71.74 %) were mild. None of the adverse events were related to the study drug and did not result in the patient’s withdrawal from the study. According to the results of RheoSTAT-CP0620, Rheosorbilact is an effective and safe drug for the treatment of patients with sepsis. It is advisable to include Rheosorbilact in routine treatment algorithms for patients with sepsis.

Keywords: sepsis, infusion therapy, Rheosorbilact, intoxication, multiorgan failure

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Published
2022-05-16
How to Cite
Sharipova, V., Beridze, S., Pidmurniak, O., Shanazarov, N., Kobeliatskyi, Y., Koshlya, V., Peev, S., Babunashvili, N., Cojocaru, V., Bely, A., Kanikovskyi, O., & Pyrtsak, I. (2022). The first data on international multicenter clinical study RheoSTAT-CP0620 on the efficacy and safety of Rheosorbilact® infusion in therapy of sepsis. Infusion & Chemotherapy, (2), 11-20. https://doi.org/10.32902/2663-0338-2022-2-11-20
Issue
No. 2 (2022): INFUSION & CHEMOTHERAPY
Section
ORIGINAL STUDIES

Author Biographies

V.Kh. Sharipova, Republican Scientific Center of Emergency Medical Aid, Tashkent, Uzbekistan

Sharipova Visolat Khamzaevna
Chief researcher, head of anesthesiology department
MD.
2, Farkhadskaya st., Tashkent, 100081, Uzbekistan.

S. Beridze, JSC EVEX Medical Corporation / Batumi State University named after Shota Rustaveli, Georgia

Beridze Sophio
Director of quality medicine and pharmacy of the EVEX Medical Corporation, head of basic medicine department of the Batumi state university named after Shota Rustaveli.
MD, professor.
125, Bagrationi st., Batumi, 6010, Georgia.
E-mail: s.beridze@evex.ge

O.O. Pidmurniak, Vinnytsia National Medical University named after М.І. Pyrogov / Khmelnytskyi Regional Hospital, Ukraine

Pidmurniak Oleksandr Oleksandrovych
Head of general and reconstructive surgery department of the Khmelnytskyi regional hospital.
MD, professor.
1, Pilotska st., Khmelnytskyi, 29000, Ukraine.

N.A. Shanazarov, Medical Centre Hospital of President’s Affairs Administration of the Republic of Kazakhstan, Nur-Sultan, Kazakhstan

Shanazarov Nasrulla Abdullaevich
Medical centre Hospital of President’s affairs administration of the Republic of Kazakhstan.
2, E495 st., Nur-Sultan, 010000, Kazakhstan.

Yu.Yu. Kobeliatskyi, Dnipro State Medical University, Dnipro, Ukraine

Kobeliatskyi Yurii Yuriiovych
Head of anesthesiology and intensive care department
MD, professor.
14, Soborna sq., Dnipro, 49005, Ukraine.

V.І. Koshlya, SI “Zaporizhzhia Medical Academy of Post-Graduate Education of the Ministry of Health of Ukraine”, Zaporizhzhia, Ukraine

Koshlya Volodymyr Ivanovych
MD, professor.
1, Schastlyva, Zaporizhzhia, 69065, Ukraine.

S.B. Peev, SI “Institute of General and Urgent Surgery named after V.T. Zaitsev of the National Academy of Medical Sciences of Ukraine”, Kharkiv, Ukraine

Peev Stanislav Borysovych
PhD.
1, Balakireva entrance, Kharkiv, 61018, Ukraine.

N. Babunashvili, JSC EVEX/LTD – Kutaisi Emergency Referral Hospital, Kutaisi, Georgia

Babunashvili Nino
Head of anesthesiology and intensive care department
2, Okcheli st., Kutaisi, 4600, Georgia.

V. Cojocaru, Republican Clinical Hospital, Chisinau, Moldova

Cojocaru Victor Ivanovich
Director of anesthesia and resuscitation clinic.
MD, professor.
29, N. Testemitsanu, Chisinau, 2025, Moldova.

A. Bely, Institute of Ambulance, Chisinau, Moldova

Bely Adrian
Head of anesthesia and intensive care department
1, T. Chorba st., Chisinau, 2004, Moldova.

O.Ye. Kanikovskyi, Vinnytsia National Medical University named after М.І. Pyrogov, Vinnytsia, Ukraine

Kanikovskyi Oleh Yevhenovych
MD, professor.
92, Khmelnytskyi highway, Vinnytsia, 21000, Ukraine.

I. Pyrtsak, Municipal Clinical Hospital “Sfanta Treime”, Chisinau, Moldova

Pyrtsak Ion
Municipal clinical hospital “Sfanta Treime”.
11, A. Russo st., Chisinau, MD-2068, Moldova.

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