Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 137

Contacts and Locations

• Study Contact: Name: Young Hoon Choi, MD, MS; Phone Number: 82-2-2258-6020; Email: crzyzs@naver.com
• Study Contact Backup: Name: In Seok Lee, MD, PhD; Phone Number: 82-2-2258-6022; Email: isle@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • Seoul St. Mary's Hospital
    • Contact: Young Hoon Choi, MD, MS; Phone Number: 82-2-2258-6020; Email: crzyzs@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients between 19 and 70 years of age with acute pancreatitis, excluding post-ERCP pancreatitis.

Description

Inclusion Criteria:

• Age 19-70 years old
• Acute pancreatitis

Exclusion Criteria:

• Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Prediction of severity of acute pancreatitis using serum phosphate	Prediction of severity of acute pancreatitis using serum phosphate	48hours after admission

Collaborators and Investigators

• Sponsor: In Seok Lee
• Investigators: Principal Investigator: In Seok Lee, MD, PhD, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: KC20OISI0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No