- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03282253
Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity of Severe Acute Pancreatitis
November 23, 2017 updated by: Weiqin Li, Nanjing University School of Medicine
Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis
In this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-CoA desaturase-1(SCD-1) and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.In this prospective study, participants were divided into two groups based on serum SCD-1 concentration on admission and prospectively observe the disease severity and clinical outcomes of them.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
216
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with the diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission; we intended to include the severer cases (APACHEII score is more than 8 and Ranson score is greater than 3).
Description
Inclusion Criteria:
- Diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission;
- APACHEII score is more than 8 and Ranson score is greater than 3;
- Age 18-75;
- Obtaining informed consent.
Exclusion Criteria:
- Pregnancy pancreatitis;
- Patients with the following disease history: severe cardiac, pulmonary, renal, liver function insufficiency or immunodeficiency disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the incidence rate of infected pancreatic necrosis
Time Frame: 2-4 week after disease onset
|
2-4 week after disease onset
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the incidence rate of organ failure
Time Frame: 1-2 week after disease onset
|
the incidence rate of organ failure (transient or persistent)
|
1-2 week after disease onset
|
|
the incidence rate of local complications
Time Frame: 1-2 week after disease onset
|
acute peripancreatic fluid collections, pancreatic pseudocycts, acute necrotic collections and walled-off necrosis
|
1-2 week after disease onset
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2018
Primary Completion (Anticipated)
December 30, 2018
Study Completion (Anticipated)
June 30, 2019
Study Registration Dates
First Submitted
September 12, 2017
First Submitted That Met QC Criteria
September 12, 2017
First Posted (Actual)
September 13, 2017
Study Record Updates
Last Update Posted (Actual)
November 27, 2017
Last Update Submitted That Met QC Criteria
November 23, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESCDEPDSSAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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