NCT04079777

Brief Summary

Plasma mtDNA analysis aids in predicting pancreatic necrosis in severe acute pancreatitis patients.After the onset of severe acute pancreatitis, pancreatic necrosis and the content of mtDNA in plasma will increase, showing a significant positive correlation.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

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

July 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

August 30, 2019

Last Update Submit

September 4, 2019

Conditions

Keywords

Mitochondrial DNA ;mtDNA;Acute pancreatitis;SAP;severe acute pancreatitis;Acute pancreatic necrosis;Inflammatory necrosis;

Outcome Measures

Primary Outcomes (1)

  • mtDNA

    mtDNA content In plasma

    one day after onset to clinical cure

Study Arms (2)

Clinical diagnosis of severe acute pancreatitis

1, with typical clinical manifestations, such as abdominal pain or nausea and vomiting, accompanied by epigastric tenderness or peritoneal irritation. 2\. Pancreatin content in serum, urine or abdominal cavity puncture fluid increases. 3\. Image examination (ultrasound, CT) showed pancreatic inflammation or pancreatic inflammation seen by surgery or confirmed by autopsy pathology. 4, can except other similar clinical manifestations of lesions.

Drug: Clinical treatment

mtDNA

Mitochondrial DNA is the genetic material in mitochondria. Mitochondria can produce energy (ATP) for cells, which is a special form of ribonucleic acid found in mitochondria of cells. Mitochondria are organelles that provide energy (ATP) to cells. There are usually many DNA molecules in a mitochondria. They carry their own DNA--mtDNA, and mutations in these genes can cause mitochondrial diseases. Although the symptoms of the disease are changeable, organs that consume more energy, such as brain, muscle and heart, are usually affected. Since mitochondria are transmitted through egg cells, related diseases will be inherited from the mother.

Drug: Clinical treatment

Interventions

Liquid Resuscitation, Anti-infection

Also known as: Clinical treatment such as fluid infusion
Clinical diagnosis of severe acute pancreatitismtDNA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute severe pancreatitis patients admitted to hospital emergency department

You may qualify if:

  • Clinical diagnosis of severe acute pancreatitis
  • Admission time less than two days

You may not qualify if:

  • Malignant Tumor
  • Positive confirmed pregnancy or urinary pregnancy test
  • Acute liver failure
  • Immunosuppressive state
  • Hormone use
  • Transplantation
  • Death within seven days
  • Blood transfusion over 1000ml in seven days
  • Missing Visits
  • Incomplete information
  • Family Requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Chenzhou

Chenzhou, Hunan, 450003, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Dixian DX

    First People's Hospital of Chenzhou

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical Care Medicine

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 6, 2019

Study Start

July 1, 2018

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations