J Korean Med Sci.
2019 Apr;34(14):e110. 10.3346/jkms.2019.34.e110.
Procalcitonin-Guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients (PRODA): a Multi-Center Randomized Controlled Trial
- Affiliations
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- 1Department of Critical Care Medicine, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Korea.
- 2Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Korea.
- 3National Evidence-based Healthcare Collaborating Agency, Ministry of Health and Welfare, Korea.
- 4Department of Information Statistics, Andong National University, Andong, Korea.
- 5Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
- 6Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
- 7Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- 8Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
- 9Department of Internal Medicine, Chung Ang University College of Medicine, Seoul, Korea.
- 10Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea. sangmin2@snu.ac.kr
- KMID: 2442645
- DOI: http://doi.org/10.3346/jkms.2019.34.e110
Abstract
- BACKGROUND
The objective of this study was to establish the efficacy and safety of procalcitonin (PCT)-guided antibiotic discontinuation in critically ill patients with sepsis in a country with a high prevalence of antimicrobial resistance and a national health insurance system.
METHODS
In a multi-center randomized controlled trial, patients were randomly assigned to a PCT group (stopping antibiotics based on a predefined cut-off range of PCT) or a control group. The primary end-point was antibiotic duration. We also performed a cost-minimization analysis of PCT-guided antibiotic discontinuation.
RESULTS
The two groups (23 in the PCT group and 29 in the control group) had similar demographic and clinical characteristics except for need for renal replacement therapy on ICU admission (46% vs. 14%; P = 0.010). In the per-protocol analysis, the median duration of antibiotic treatment for sepsis was 4 days shorter in the PCT group than the control group (8 days; interquartile range [IQR], 6-10 days vs. 14 days; IQR, 12-21 days; P = 0.001). However, main secondary outcomes, such as clinical cure, 28-day mortality, hospital mortality, and ICU and hospital stays were not different between the two groups. In cost evaluation, PCT-guided therapy decreased antibiotic costs by USD 30 (USD 241 in the PCT group vs. USD 270 in the control group). The results of the intention-to-treat analysis were similar to those obtained for the per-protocol analysis.
CONCLUSION
PCT-guided antibiotic discontinuation in critically ill patients with sepsis could reduce the duration of antibiotic use and its costs with no apparent adverse outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02202941
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