[Effect of perioperative antibiotic prophylaxis on hemodynamic stability during surgery: detection of complex interaction in a simulated clinical randomized animal study].
In a clinic modelling randomised trial (CMRT) in three groups of 10 land-race pietren pigs each it could be shown that the influence of prophylactic antibiotic administration on intraoperative hemodynamic stability and histamine release is only evident, if by stepwise addition of complicating factors the overall complexity of the experimental setting is increased. Different antibiotic regimen for prophylaxis significantly affected the incidence of cardiovascular instabilities only after relevant blood loss, restoration of circulation and subsequent submaximal induction of anaphylactoid reactions by the histamine liberator Polymyxin B. In conclusion, preclinical testing of therapeutic agents in complex clinic modelling randomised trials should be mandatory to avoid the possible hazards of misconducted clinical trials.
D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000009:adverse effects; D000818:Animals; D019072:Antibiotic Prophylaxis; D016063:Blood Loss, Surgical / Q000503:physiopathology*; D002444:Cefuroxime / Q000008:administration & dosage / Q000009:adverse effects; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006439:Hemodynamics / Q000187:drug effects* / Q000502:physiology; D006636:Histamine Release / Q000187:drug effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D012771:Shock, Hemorrhagic / Q000503:physiopathology / Q000517:prevention & control*; D013530:Surgical Wound Infection / Q000503:physiopathology / Q000517:prevention & control*; D013552:Swine
D008795:Metronidazole; D019980:Amoxicillin-Potassium Clavulanate Combination; D002444:Cefuroxime