Aim: Evaluating the impact of vitamin K prophylaxis on cefoperazone-sulbactam-induced coagulopathy in critically ill patients. Methods: We conducted a randomized controlled trial on critically ill adult patients treated with cefoperazone-sulbactam. Patients received systemic cefoperazone-sulbactam antibiotics of 1.5 to 2 g every 12 hours. Patients were randomized into 2 groups: the intervention group (Gp-I), who received a 10 mg intravenous dose of vitamin K every week until cefoperazone-sulbactam therapy ended, and the control group (Gp-C), who received only cefoperazone-sulbactam. Results: Our main finding was the significantly higher survival probability from coagulopathy in Gp-I than in Gp-C using the Kaplan-Myers curve (χ2 = 25.5, P < .001). The adjusted hazard ratios for coagulopathy obtained from the Cox regression analysis revealed that the intervention was significantly associated with a 99% reduction in the hazard of coagulopathy relative to Gp-C (HR = 0.01, P = .001). The Kaplan-Myers curve indicated a significantly higher survival probability from bleeding in Gp-I than in Gp-C (χ2 = 9, degree of freedom = 1, P = .005). Conclusion: In critically ill patients, intravenous prophylactic doses of vitamin K of 10 mg per week prevent cefoperazone-sulbactam-induced coagulopathy. Therefore, we recommend adding vitamin K supplementation to ICU protocols in Egypt for cefoperazone-sulbactam safety.
Keywords: adverse drug reactions; anti-infectives; critical care; infectious diseases; medication safety; vitamins.
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