Pancreatitis, AcutePhase 4NCT03342807
Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
A Phase 4 study testing Insulin and Aphesis in people with Pancreatitis, Acute and Hypertriglyceridemia, run by Peking Union Medical College Hospital.
Trial summary
To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatitis, Acute, Hypertriglyceridemia
- What is being tested?
- Insulin and Aphesis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Nov 2020
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 18 to 80 years old;
- abdominal pain consistent with AP;
- serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
- abdominal imaging consistent with AP imaging changes.
- severe hyperlipidemia "fasting serum TG> 1,000 mg/dL (11.2mmol/L)";
- except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.
Who cannot join
- other etiologies other than hyperlipidemia leading to AP;
- fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
- acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
- the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia.
- without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
About this study
Official title: Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.
- Conditions
- Pancreatitis, Acute, Hypertriglyceridemia
- Being tested
- Insulin, Aphesis
- Keywords
- Hypertriglyceridemia-induced acute pancreatitis, insulin, triglyceride, treatment
- Medical subject headings
- Pancreatitis, Hypertriglyceridemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin infusion for subjects in Group Insulin.
AphesisDevice
Aphesis for subjects in Group Aphesis.
| Study group | Role | What they receive |
|---|---|---|
| Group Insulin | Experimental | Not described Receives: Drug: Insulin |
| Group Aphesis | Experimental | Not described Receives: Device: Aphesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum TG
Elimination of serum triglyceride.
Measured: every 4 hours in first 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startNov 2017 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital, Nanjing General Hospital, Fujian Provincial Hospital, First Affiliated Hospital, Sun Yat-Sen University, Jinhua Central Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University General Hospital, The First Hospital of Hebei Medical College, The First Affiliated Hospital with Nanjing Medical University, Shenzhen Baoan District People's Hospital, General Hospital of Shenyang Military Region, Cangzhou Center Hospital, Wuxi Third People 's Hospital, General Hospital of Ningxia Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342807
- Sponsor's protocol ID
- HTG-AP-Insulin
- Status last verified
- Aug 2017
- First submitted
- 5 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Song X, Shi D, Cui Q, Yu S, Yang J, Song P, Walline J, Xu J, Zhu H, Yu X. Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial. Trials. 2019 Jun 18;20(1):365. doi: 10.1186/s13063-019-3498-x.
PubMed 31215460
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
- ClinicalTrials.gov ID
- NCT03342807
- Acronym / sponsor ID
- HTG-AP-Insulin
- Conditions
- Pancreatitis, Acute, Hypertriglyceridemia
- Keywords
- Hypertriglyceridemia-induced acute pancreatitis, insulin, triglyceride, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital, Nanjing General Hospital, Fujian Provincial Hospital, First Affiliated Hospital, Sun Yat-Sen University, Jinhua Central Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University General Hospital, The First Hospital of Hebei Medical College, The First Affiliated Hospital with Nanjing Medical University, Shenzhen Baoan District People's Hospital, General Hospital of Shenyang Military Region, Cangzhou Center Hospital, Wuxi Third People 's Hospital, General Hospital of Ningxia Medical University
- Study start
- Nov 2017 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 17 Nov 2017 (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.
To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Insulin | Experimental | Drug: Insulin |
| Group Aphesis | Experimental | Device: Aphesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult aged 18 to 80 years old;
- abdominal pain consistent with AP;
- serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
- abdominal imaging consistent with AP imaging changes.
- severe hyperlipidemia "fasting serum TG> 1,000 mg/dL (11.2mmol/L)";
Key exclusion criteria (5 listed)
- other etiologies other than hyperlipidemia leading to AP;
- fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
- acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
- the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia.
- without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
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 |
|---|---|---|
| InsulinInsulin infusion for subjects in Group Insulin. | Drug | Group Insulin |
| AphesisAphesis for subjects in Group Aphesis. | Device | Group Aphesis |
Primary outcome
serum TG
Time frame: every 4 hours in first 3 days
Elimination of serum triglyceride.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 31215460Song X, Shi D, Cui Q, Yu S, Yang J, Song P, Walline J, Xu J, Zhu H, Yu X. Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial. Trials. 2019 Jun 18;20(1):365. doi: 10.1186/s13063-019-3498-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin and Aphesis in people with Pancreatitis, Acute and Hypertriglyceridemia, run by Peking Union Medical College Hospital.
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 6 inclusion and 5 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum TG (time frame: every 4 hours in first 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03342807, which also lists 1 linked publication.
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 17 Nov 2017.