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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04553783
Other study ID # KC20OISI0022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2020
Est. completion date May 2023

Study information

Verified date September 2020
Source Seoul St. Mary's Hospital
Contact Young Hoon Choi, MD, MS
Phone 82-2-2258-6020
Email crzyzs@naver.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to evaluate the usefulness of blood viscosity as a prognostic factor in patients with acute pancreatitis. The study design is a single-arm prospective cohort observational study. Blood biomarkers including blood viscosity, C-reactive protein, hematocrit, and phosphate are measured and the correlation with the severity of acute pancreatitis will be analyzed.


Description:

Several scoring systems are used to evaluate the prognosis of acute pancreatitis, but they are rather complicated and clinically less useful. Blood viscosity is associated with hematocrit and inflammatory factors known to be related to the prognosis of acute pancreatitis, and our group's previous study which is not yet published showed that blood viscosity better predicts severe acute pancreatitis than other single factors such as C-reative protein. Therefore, this study aims to prospectively evaluate the usefulness of blood viscosity as a prognostic factor for acute pancreatitis. During the study period, the study is conducted on patients with acute pancreatitis between the ages of 19 and 70, and patients with acute pancreatitis after ERCP are excluded. Blood viscosities at initial and 24 hours after hospitalization, and serum phosphate, which have shown potential as a predictor of severity in post-ERCP pancreatitis in previous studies are measured. The association of these blood biomarkers with the severity of acute pancreatitis will be analyzed and compared with hematocrit, C-reactive protein, etc., which are known as a single prognostic predictor of acute pancreatitis.


Recruitment information / eligibility

Status Recruiting
Enrollment 137
Est. completion date May 2023
Est. primary completion date May 2022
Accepts healthy volunteers
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria:

- Age 19-70 years old

- Acute pancreatitis

Exclusion Criteria:

- Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul St. Mary's hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
In Seok Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prediction of severity of acute pancreatitis using initial blood viscosity Evaluate initial blood viscosity as a predictor of the severity of acute pancreatitis 48hours after admission
Secondary Prediction of severity of acute pancreatitis using blood viscosity change after 24hours Prediction of severity of acute pancreatitis using blood viscosity change after 24hours 24hours after admission
Secondary Prediction of severity of acute pancreatitis using serum phosphate Prediction of severity of acute pancreatitis using serum phosphate 48hours after admission
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