Elevated Stearoyl-CoA Desaturase-1 Expression Predicts th... | NCT03282253

Studies
Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity of Severe Acute Pancreatitis

NCT03282253

Sponsor

Nanjing University School of Medicine

Status

Unknown status

Last Update Posted

Nov 27, 2017Actual

Enrollment

216Estimated

Phase

Not provided

Conditions

Acute Pancreatitis
Organ Failure, Multiple

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Dec 30, 2018Estimated

Completion Date

Jun 30, 2019Estimated

First Submitted Date

Sep 12, 2017

First Submission Date that Met QC Criteria

Sep 12, 2017

First Posted Date

Sep 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2017

Last Update Posted Date

Nov 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weiqin Li, Director of Department of Surgical Intensive Care Unit, Nanjing University School of MedicinePrincipal Investigator

Lead Sponsor

Nanjing University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

216Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence rate of infected pancreatic necrosis		2-4 week after disease onset

Secondary Outcomes

Measure	Description	Time Frame
the incidence rate of organ failure	the incidence rate of organ failure (transient or persistent)	1-2 week after disease onset
the incidence rate of local complications	acute peripancreatic fluid collections, pancreatic pseudocycts, acute necrotic collections and walled-off necrosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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).

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis
D009102	Multiple Organ Failure

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D012769	Shock
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided