Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553783
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
In Seok Lee, Seoul St. Mary's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 137 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prediction of severity of acute pancreatitis using initial blood viscosity [ Time Frame: 48hours after admission ]
    Evaluate initial blood viscosity as a predictor of the severity of acute pancreatitis


Secondary Outcome Measures :
  1. Prediction of severity of acute pancreatitis using blood viscosity change after 24hours [ Time Frame: 24hours after admission ]
    Prediction of severity of acute pancreatitis using blood viscosity change after 24hours

  2. Prediction of severity of acute pancreatitis using serum phosphate [ Time Frame: 48hours after admission ]
    Prediction of severity of acute pancreatitis using serum phosphate


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes 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.
Criteria

Inclusion Criteria:

  • Age 19-70 years old
  • Acute pancreatitis

Exclusion Criteria:

  • Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553783


Contacts
Layout table for location contacts
Contact: Young Hoon Choi, MD, MS 82-2-2258-6020 crzyzs@naver.com
Contact: In Seok Lee, MD, PhD 82-2-2258-6022 isle@catholic.ac.kr

Locations
Layout table for location information
Korea, Republic of
Seoul St. Mary's hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Young Hoon Choi, MD, MS    82-2-2258-6020    crzyzs@naver.com   
Sponsors and Collaborators
In Seok Lee
Investigators
Layout table for investigator information
Principal Investigator: In Seok Lee, MD, PhD Seoul St. Mary's Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: In Seok Lee, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT04553783    
Other Study ID Numbers: KC20OISI0022
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatitis
Pancreatic Diseases
Digestive System Diseases