MedDataX Logo

Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis

NCT ID: NCT03342807

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatitis, Acute Hypertriglyceridemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hypertriglyceridemia-induced acute pancreatitis insulin triglyceride treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Insulin

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Insulin infusion for subjects in Group Insulin.

Group Aphesis

Group Type EXPERIMENTAL

Aphesis

Intervention Type DEVICE

Aphesis for subjects in Group Aphesis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Insulin

Insulin infusion for subjects in Group Insulin.

Intervention Type DRUG

Aphesis

Aphesis for subjects in Group Aphesis.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult aged 18 to 80 years old;
2. abdominal pain consistent with AP;
3. serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
4. abdominal imaging consistent with AP imaging changes.
5. severe hyperlipidemia "fasting serum TG\> 1,000 mg/dL (11.2mmol/L)";
6. except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.

Exclusion Criteria

1. other etiologies other than hyperlipidemia leading to AP;
2. fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
3. acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
4. 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.
5. without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Hospitals affiliated to the China PLA General Hospital

OTHER_GOV

Sponsor Role collaborator

Nanjing General Hospital

UNKNOWN

Sponsor Role collaborator

Fujian Provincial Hospital Emergency Center

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical College

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Shenzhen Baoan District People 's Hospital

UNKNOWN

Sponsor Role collaborator

The General Hospital of Shenyang Military

UNKNOWN

Sponsor Role collaborator

Cangzhou Center Hospital

UNKNOWN

Sponsor Role collaborator

Wuxi Third People 's Hospital

UNKNOWN

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31215460 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HTG-AP-Insulin

Identifier Type: -

Identifier Source: org_study_id