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A randomized, open, multicenter clinical trial to evaluate the safety and efficacy of DELP in the treatment of hyperlipidemic acute pancreatitis

A randomized, open, multicenter clinical trial to evaluate the safety and efficacy of DELP in the treatment of hyperlipidemic acute pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083307
Enrollment
Unknown
Registered
2024-04-22
Start date
2024-04-22
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemic acute pancreatitis

Interventions

Experimental group:Plasma adsorption filtration therapy plus conventional therapy
Control group:Conventional treatment

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Male and female, 18 years old = age =70 years old; 2) Meet the diagnostic criteria for acute pancreatitis, and the onset time is not more than 7 days: the diagnostic criteria for acute pancreatitis It may include the following three items: ? persistent pain in the upper abdomen. ? Serum amylase and/or lipase concentration At least 3 times higher than the normal upper limit. ? Abdominal imaging findings were consistent with acute pancreatitis Learn to change. If 2 of the above 3 criteria are met, acute pancreatitis is diagnosed. 3) Serum TG level =1000mg/dL (11.30mmol/L); 4) The patient agrees to participate in the trial, voluntarily signs the informed consent, and agrees to participate in all visits, examinations and treatments as required by the trial protocol.

Exclusion criteria

Exclusion criteria: 1) Allergic to in vitro adsorption-related drugs (such as heparin, protamine, etc.), instruments or plasma; 2) Received hyperlipidemic acute pancreatitis treatment drugs or lipid-lowering measures within 30 days before randomization, can Who can influence the evaluation of test results; 3) Severe bleeding tendency, active bleeding, disseminated intravascular coagulation or severe coagulation dysfunction (PTA=20%) or platelet count less than 50×10^9/L; 4) Severe hypertension (systolic blood pressure > 220 mmHg), severe anemia (hemoglobin < 60g/L), severe infection, malignant tumor or severe heart or lung insufficiency (unable to tolerate extracorporeal circulation); 5) Patients with previous heparin-induced thrombocytopenia; 6) Subjects had received blood purification treatment (e.g., kidney replacement therapy, plasma placement) within 1 month before enrollment Exchange, hemoperfusion, etc.); 7) Participants in other clinical trials; 8) Pregnant and lactating women; 9) The researcher judges that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
The decrease of serum triglycerides immediately after the end of the last treatment compared with the value before treatment;

Secondary

MeasureTime frame
The reduction in subjects' triglyceride levels before and after each treatment;Therapeutic effectiveness of triglyceride in subjects;Changing value in serum levels of IL-6, creatinine, urea nitrogen, C-reactive protein and procalcitonin after treatment;Incidence of multiple organ failure and new local complications within 28 days;Incidence and duration of systemic inflammatory response syndrome within 28 days;Total hospital stay;

Countries

China

Contacts

Public ContactDu Yiqi

Shanghai Changhai Hospital

duyiqi@hotmail.com+86 21 3116 1344

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026