A Multicenter, International Cohort Analysis of 1435 Cases to Support Clinical Trial Design in Acute Pancreatitis
Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic-ecollection
Typ dokumentu časopisecké články
PubMed
31551798
PubMed Central
PMC6738025
DOI
10.3389/fphys.2019.01092
Knihovny.cz E-zdroje
- Klíčová slova
- C-reactive protein, acute pancreatitis, sample size calculation, trial design, white blood cell,
- Publikační typ
- časopisecké články MeSH
BACKGROUND: C-reactive protein level (CRP) and white blood cell count (WBC) have been variably used in clinical trials on acute pancreatitis (AP). We assessed their potential role. METHODS: First, we investigated studies which have used CRP or WBC, to describe their current role in trials on AP. Second, we extracted the data of 1435 episodes of AP from our registry. CRP and WBC on admission, within 24 h from the onset of pain and their highest values were analyzed. Descriptive statistical tools as Kruskal-Wallis, Mann-Whitney U, Levene's F tests, Receiver Operating Characteristic (ROC) curve analysis and AUC (Area Under the Curve) with 95% confidence interval (CI) were performed. RESULTS: Our literature review showed extreme variability of CRP used as an inclusion criterion or as a primary outcome or both in past and current trials on AP. In our cohort, CRP levels on admission poorly predicted mortality and severe cases of AP; AUC: 0.669 (CI:0.569-0.770); AUC:0.681 (CI: 0.601-0.761), respectively. CRP levels measured within 24 h from the onset of pain failed to predict mortality or severity; AUC: 0.741 (CI:0.627-0.854); AUC:0.690 (CI:0.586-0.793), respectively. The highest CRP during hospitalization had equally poor predictive accuracy for mortality and severity AUC:0.656 (CI:0.544-0.768); AUC:0.705 (CI:0.640-0.769) respectively. CRP within 24 h from the onset of pain used as an inclusion criterion markedly increased the combined event rate of mortality and severe AP (13% for CRP > 25 mg/l and 28% for CRP > 200 mg/l). CONCLUSION: CRP within 24 h from the onset of pain as an inclusion criterion elevates event rates and reduces the number of patients required in trials on AP.
1st Department of Medicine University of Szeged Szeged Hungary
Bajcsy Zsilinszky Hospital Budapest Hungary
Borsod Abaúj Zemplén County Hospital University Teaching Hospital Miskolc Hungary
Centrum Péče o Zažívací Trakt Vítkovická Nemocnice a s Ostrava Czechia
Clinical Medicine Doctoral School University of Szeged Szeged Hungary
Consorci Sanitari del Garraf Barcelona Spain
Department of Gastroenterology Bács Kiskun County Hospital Kecskemét Hungary
Dr Bugyi István Hospital Szentes Hungary
Dr Réthy Pál Hospital Békéscsaba Hungary
Heim Pál National Institute of Pediatrics Budapest Hungary
Institute for Translational Medicine Medical School University of Pécs Pécs Hungary
Institute of Bioanalysis Medical School University of Pécs Pécs Hungary
Pándy Kálmán Hospital of County Békés Gyula Hungary
Saint Luke's Clinical Hospital St Petersburg Russia
School of Medicine Hospital of Bezmialem Vakif University Istanbul Turkey
Szent György University Teaching Hospital Fejér County Székesfehérvár Hungary
Vilnius University Hospital Santariskiu Klinikos Vilnius Lithuania
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