Severe Acute PancreatitisNCT04079777
Relationship Between Acute Severe Pancreatitis and Mitochondrial DNA
An observational study of Severe Acute Pancreatitis, run by First People's Hospital of Chenzhou at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Pancreatitis
- What is being tested?
- Clinical treatment
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to Jun 2020
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute severe pancreatitis patients admitted to hospital emergency department
Who may be able to join
- Clinical diagnosis of severe acute pancreatitis
- Admission time less than two days
Who cannot join
- Malignant Tumor
- Positive confirmed pregnancy or urinary pregnancy test
- Acute liver failure
- Immunosuppressive state
- Hormone use
- Transplantation
Show all 11Show fewer
- Death within seven days
- Blood transfusion over 1000ml in seven days
- Missing Visits
- Incomplete information
- Family Requirements
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Severe Acute Pancreatitis
- Being tested
- Clinical treatment
- Keywords
- Mitochondrial DNA ;mtDNA;, Acute pancreatitis;SAP;severe acute pancreatitis;, Acute pancreatic necrosis;, Inflammatory necrosis;
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical treatmentDrug
Also called Clinical treatment such as fluid infusion
Liquid Resuscitation, Anti-infection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
mtDNA
mtDNA content In plasma
Measured: one day after onset to clinical cure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jul 2018
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingui Dai, First People's Hospital of Chenzhou
- Investigators
- Dixian DX, Study director, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079777
- Sponsor's protocol ID
- severe acute pancreatitis
- Status last verified
- Sep 2019
- First submitted
- 30 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Acute Severe Pancreatitis and Mitochondrial DNA
- ClinicalTrials.gov ID
- NCT04079777
- Acronym / sponsor ID
- severe acute pancreatitis
- Conditions
- Severe Acute Pancreatitis
- Keywords
- Mitochondrial DNA ;mtDNA;, Acute pancreatitis;SAP;severe acute pancreatitis;, Acute pancreatic necrosis;, Inflammatory necrosis;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical diagnosis of severe acute pancreatitis | – | Drug: Clinical treatment1, 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. |
| mtDNA | – | Drug: Clinical treatmentMitochondrial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute severe pancreatitis patients admitted to hospital emergency department
Key inclusion criteria (2 listed)
- Clinical diagnosis of severe acute pancreatitis
- Admission time less than two days
Key exclusion criteria (11 listed)
- Malignant Tumor
- Positive confirmed pregnancy or urinary pregnancy test
- Acute liver failure
- Immunosuppressive state
- Hormone use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical treatmentAlso: Clinical treatment such as fluid infusionLiquid Resuscitation, Anti-infection | Drug | Clinical diagnosis of severe acute pancreatitis, mtDNA |
Primary outcome
mtDNA
Time frame: one day after onset to clinical cure
mtDNA content In plasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dixian DX study director
First People's Hospital of Chenzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Pancreatitis, run by First People's Hospital of Chenzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mtDNA (time frame: one day after onset to clinical cure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.