Peter Johnson, PharmD, BCPPS, FPPA
Professor of Pharmacy and Pediatric Critical Care Pharmacist
University of Oklahoma Health Sciences Center College of Pharmacy
Oklahoma City, Oklahoma
Disclosure information not submitted.
Katy Stephens, Pharm.D.
Clinical Pharmacy Specialist--NICU
Oklahoma Children's Hospital at OU Health, United States
Disclosure information not submitted.
Jamie Miller, Pharm.D., BCPS, BCPPS, FPPA
Professor and Clinical Pharmacy Specialist--NICU
University of Oklahoma College of Pharmacy, United States
Disclosure information not submitted.
Maura Harkin, Pharm.D.
Clinical Pharmacy Specialist--PICU
Oklahoma Children's Hospital at OU Health, United States
Disclosure information not submitted.
Laura Haws, M.D.
Assistant Professor
University of Oklahoma College of Medicine, United States
Disclosure information not submitted.
Title: Effect of phytonadione on correction of coagulopathy in children with septic shock
Introduction: Critically-ill children with septic shock are at risk for coagulopathy. Phytonadione is a treatment option, but there is a paucity of data regarding optimal dosing. The purpose was to evaluate phytonadione dosing and factors impacting international normalized ratio (INR).
Methods: Patients < 18 years of age receiving IV/IM phytonadione from 10/1/2013-8/31/2020 with septic shock were included. They were excluded if they received warfarin or chronic phytonadione, or had hepatic disease. Data collection included demographics, phytonadione regimen, INRs, Pediatric Index of Mortality 2 (PIM2) and Pediatric Risk of Mortality III (PRISM III) scores, fresh frozen plasma (FFP) or cryoprecipitate use, and phytonadione adverse drug events (ADEs). The primary objective was comparison of median phytonadione dose between patients with post-treatment INR < 1.2 versus INR >1.2. Secondary objectives were to identify phytonadione ADEs and determine factors associated with an INR <1.2. A least-means square analysis was used to compare the median cumulative dose between groups, controlling for confounding variables (PIM2, PRISM III, and FFP/cryoprecipitate use). A logistic regression model was used to assess the relationship of an INR <1.2 and independent variables (PIM2, PRISM III, FFP/cryoprecipitate use, vasopressor use, and cumulative phytonadione dose).
Results: Data for 156 patients were included with 160 separate phytonadione courses. Sixty-eight courses (45.6%) had an INR of <1.2 post-treatment. A greater percentage of patients received FFP in the INR >1.2 versus <1.2 group, 50 (62.5%) versus 28 (42.4%), p=0.016. No difference in cryoprecipitate was noted between groups. No statistical difference was found in the mean cumulative dose (IQR) in patients with a post-phytonadione INR <1.2 versus INR >1.2, 0.74 (0.54-0.94) versus 0.61 (0.44-0.77) mg/kg, p=0.162, respectively. Concomitant cryoprecipitate/phytonadione was associated with an INR <1.2 [Adjusted odds ratio, 3.13, 95% CI 1.14-8.61; p=0.027). Cumulative phytonadione dose was not associated with an INR <1.2.
Conclusions: Less than half achieved an INR <1.2. No difference in phytonadione dosing was noted between those with a post-treatment INR <1.2 versus >1.2. Cumulative phytonadione dose had no impact on INR achievement when controlling for other variables.