NCT04553783

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

June 3, 2020

Last Update Submit

September 15, 2020

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Prediction of severity of acute pancreatitis using blood viscosity change after 24hours

    24hours after admission

  • Prediction of severity of acute pancreatitis using serum phosphate

    48hours after admission

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age 19-70 years old
  • Acute pancreatitis

You may not qualify if:

  • Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • In Seok Lee, MD, PhD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Hoon Choi, MD, MS

CONTACT

82-2-2258-6020crzyzs@naver.com

In Seok Lee, MD, PhD

CONTACT

82-2-2258-6022isle@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2020

First Posted

September 17, 2020

Study Start

March 10, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2023

Last Updated

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)