CLINICAL PHARMACOLOGY UNIT

Clinical studies, drug safety is most important!

MVDr. Ing. Václav Trojan, Ph.D.

Research focus
The Clinical Pharmacology Unit (CPU) is a certified Unit working under ISO 9001, GCP and national legislati­on. It executes clinical trials with pharmaceuticals or medical devices (phases I., II., III. and IV.). Main interests are pharmacokinetics (PK) and pharmacodynamics (PD) of the drug and its early phase of development. In this field, CPU realizes sponsored as well as academic studies. GMO based substances are able to test. The latest academic trial had the aim to study the influence of different drug application forms used in the intensive care unit during nasogastric tube (NGT) applications. One of the topics of CPU is the handling and monitoring of sepsis in intensive care. Other study topics are from the field of rheumatology (Phase I), gastroenterology (Phase II), diabetology (Phase I) and oncology (Phase I). As an important step to provide IIT clinical trials, the unit prepares their own protocols. Since 2019 CPU has been developing clinical cannabis research as the first Centre in Czech Republic. Cannabis growing and medicament production is GMP and GACP certified.

Research objectives

  • To change Pk/Pd of the drugs primarily in the critically ill.
  • To improve the results of perioperative care in high-risk patients.
  • To grow medical cannabis according to the GMP standard.
  • To produce new forms of cannabis in Hospital pharmacies.
  • To study the effect of cannabis on patients (current/new).
  • To study and confirm cannabis product safety.
  • Contract research.

Main partners

  • Masaryk Memorial Cancer Institute, Brno, Czech Republic Thomayer Hospital, Prague, Czech Republic, Masaryk University Brno, Czech Republic
  • University of Veterinary and Pharmaceutical Sciences Brno, Brno, Czech Republic

Offered services and expertise

  • Complete service for conducting clinical trials
  • Pk/Pd of various drugs in different patient groups and diseases
  • Sepsis in the critically ill
  • Monitoring of haemodynamics (invasive and non-invasive)
  • Suitable conditions for GMO substances use

Top publications

  • Zvonicek, V., Jurak, P., Halamek, J., Kruzliak, P., Vondra, V., Leinveber, P., Cundrle, I., Pavlik, M., Suk, P., Sramek, V. The impact of sedation on pulse pressure variation. Australian Critical Care. 2015, 28(4), 203-207.
  • Ruzsikova, A., Souckova, L., Suk, P., Opatrilova, R., Kejdusova, M., Sramek, V., Quantitative analysis of drug losses administered via nasogastric tube – In vitro study. International Journal of Pharmaceutics. 2015, 478 (1), 368-371.
  • Rautanen, A., Mills, T. C., Gordon, A. C., Hutton, P., Steffens, M., Nuamah, R., Chiche, J.-D., Parks, T., Chapman, S. J., Davenport, E. E., Elliott, K. S., Bion, J., Lichtner, P., Meitinger, T., Wienker, T. F., Caulfield, M. J., Mein, C., Bloos, F., Bobek, I., Cotogni, P., Sramek, V., Sarapuu, S., Kobilay, M., Ranieri, V. M., Rello, J., Sirgo, G., Weiss, Y. G., Russwurm, S., Schneider, E. M., Reinhart, K., Holloway, P. A. H.,Knight, J. C., Garrard, C. S., Russell, J. A., Walley, K. R., Stueber, F., Hill, A. V. S., Hinds, C. J., Investigators, E.-E. G., Genome-wide association study of survival from sepsis due to pneumonia: an observational cohort study. Lancet Respiratory Medicine. 2015, 3 (1), 53-60.
  • Cundrle, I., Jr., Sramek, V., Pavlik, M., Suk, P., Radouskova, I., Zvonicek, V., Temperature corrected thromboelastography in hypothermia. Is it necessary? European Journal of Anaesthesiology. 2013, 30 (2), 85-89.
  • Souckova, L.,Opatrilova, R., Suk, P., Cundrle, I., Jr., Pavlik, M., Zvonicek, V., Hlinomaz, O., Sramek, V., Impaired bioavailability and antiplatelet effect of high-dose clopidogrel in patients after cardiopulmonary resuscitation (CPR). European Journal of Clinical Pharmacology. 2013, 69 (3), 309-317.

Other selected results

  • Clopidogrel is not absorbed in cardiac patients after CPR (see publ. Součková et al. 2013)
  • There are significant losses of the drugs given via NGT. Losses are dependent on the method of preparation/application (see publ. Zvoníček et al. 2015)
  • CVVH with citrate anticoagulation is feasible for the treatment of hypercalcemia with AKI (see publ. Šrámek et al. 1998)