ClinicalTrials.gg
Status unknownNCT04079777Updated Sep 6, 2019

Relationship Between Acute Severe Pancreatitis and Mitochondrial DNA

An observational study in Severe Acute Pancreatitis, sponsored by First People's Hospital of Chenzhou. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by First People's Hospital of Chenzhou · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Acute pancreatitis is an acute inflammatory disease of the pancreas characterized by the sudden onset of abdominal pain, elevated serum amylase, and edema or necrosis of the pancreas. The clinical course of AP is generally mild; however, nearly 25% of patients progress into severe AP which consists of organ failure and/or pancreatic necrosis. Although advances in the diagnosis and management have been made, AP remains a major health issue to the society. PNec is a major complication of AP which manifests as non-opacified parenchyma with intravenous contrast, as identified via contrast-enhanced CT scan. Patients with PNec are more likely to develop pancreatic infection and suffer a greater risk for mortality . Currently, CECT scans remain the "gold standard" to diagnosis PNec clinically. However, the extent of PNec is best seen about 3 days after the presentation of disease and may be missed in early CT scan. In addition, repeated CT scanning is not convenient to monitor changes in necrosis, most notably for those who are receiving mechanical ventilation or hemofiltration.The clinical diagnosis of AP is based on the presence of the following features: abdominal pain; serum amylase and/or lipase levels three times higher than the upper limit of normal; and characteristic findings of AP on CT scan.

Specific plasma biomarkers in predicting pancreatic necrosis (PNec) are needed in treating acute pancreatitis (AP). Aims To investigate the prognostic value of plasma mitochondrial DNA fragments (mtDNA) in patient with AP for PNec. Methods AP patients with symptoms onset within 72 h were prospectively enrolled.The conclusions elevated plasma mtDNA content in AP patients may be used as a more accurate early predictor of PNec in contrast to traditional CRP.

Normally,human mtDNA is strictly contained in mitochondria and not exposed to the innate immune system even following cell apoptosis. However, in times of cell death elicited by stress (e.g., trauma and sepsis), mtDNA is released into systemic circulation and leads to an array of inflammatory reactions. Elevated mtDNA levels have been reported in a variety of clinical situations, including trauma, severe sepsis, and cancer. As PNec is caused by intracellular activation of digestive enzymes and autodigestion, we assumed that circulating mtDNA levels could be used as a biomarker for early detection of PNec.

Research methods and steps:cell culture and mtDNA extraction、mtDNA detection、statistical analysis、results.

02

Conditions studied

  • Severe Acute Pancreatitis

Browse trials for

Keywords

  • Mitochondrial DNA ;mtDNA;
  • Acute pancreatitis;SAP;severe acute pancreatitis;
  • Acute pancreatic necrosis;
  • Inflammatory necrosis;
03

In context

Pancreatitis

759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 50 is below the median of 179 across 282 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

First People's Hospital of Chenzhou is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Acute severe pancreatitis patients admitted to hospital emergency department

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • DrugClinical treatment

    Liquid Resuscitation, Anti-infection

    Also known as: Clinical treatment such as fluid infusion

06

What researchers measure

Primary outcomes

  1. mtDNA

    mtDNA content In plasma

    Time frame: one day after onset to clinical cure

07

Study locations

1 site
  • The First Hospital of Chenzhou
    Chenzhou, Hunan 450003, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04079777
Lead sponsor
First People's Hospital of Chenzhou
Responsible party
Xingui Dai (Critical Care Medicine, First People's Hospital of Chenzhou) — Principal investigator
First posted
Sep 6, 2019
Start date
Jul 1, 2018
Primary completion
Dec 2019 (estimated)
Completion
Jun 2020 (estimated)
Last update
Sep 6, 2019

Study contacts

Dixian DX
study director · First People's Hospital of Chenzhou

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion