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Low-molecular-weight heparin combined insulin regimen VS insulin: the efficacy and prognosis in acute lipid-lowering therapy for hypertriglyceridaemia pancreatitis: a multicenter, prospective, open label, randomized, controlled study

Low-molecular-weight heparin combined insulin regimen VS insulin: the efficacy and prognosis in acute lipid-lowering therapy for hypertriglyceridaemia pancreatitis: a multicenter, prospective, open label, randomized, controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023640
Enrollment
Unknown
Registered
2019-06-05
Start date
2019-06-01
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

hypertriglyceridemic pancreatitis

Interventions

Group A:Low molecular weight heparin combined with insulin
Group B:insulin

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 85 years; 2. Meet the diagnostic criteria of acute pancreatitis; 3. Acute pancreatitis onset =11.30 mmol/L and <40 mmol/L; 5. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient had biliary causes at the same time, a biliary etiology was defined as the presence of dilated CBD, or two of the following three laboratory abnormalities: (1) serum bilirubin concentration > 1.9 mg/dL; (2) alanine aminotransferase (ALT) activity > 100 U/L with an ALT activity higher than the aspartate aminotransferase (AST) activity; and (3) alkaline phosphatase activity > 195 U/L with a ?-glutamyltransferase (GGT) activity > 45 U/L. 2. Patient has a history of over 5 years of heavy alcohol consumption (> 50 g per day). 3. Pregnant or lactating women; 4. Disseminated intravascular coagulation, or active bleeding; 5. Those who are allergic to heparin or insulin; 6. Those who had received lipid-lowering therapy, plasma exchange or hemofiltration before admission;Or patients who require blood purification treatment due to acute renal failure 7. Cardiopulmonary resuscitation due to cardiac arrest; 8. Patients with irreversible organ failure or other critical manifestations who are expected to die within 24 hours, including patients with severe ARDS requires in vitro life support (PEEP>10 cm H2O, FiO2=100%, FiO2/ PO2<60); severe systemic circulatory failure, (under full-fluid resuscitation and norepinephrine usage at a dose of 25 ug/ min, with a systolic blood pressure <90mm Hg and serum pH values <7.0); Severe coma without sedation drugs and who had a Glasgow score=3 points. 9. Advanced malignant tumors, immunodeficiency disorders, and Patients who required regular hemodialysis for a preexisting chronic kidney disease. 10. Persons whose conscious and behavioral abilities are partially or totally limited and unable to make decisions independently.

Design outcomes

Primary

MeasureTime frame
A composite of new-onset organ failure and mortality;Vein thrombosis;Sinistral portal hypertension;Abdominal compartment syndrome;Cerebral hemorrhage;The demand for mechanical ventilation;Renal replacement therapy;Percutaneous drainage of ascites;Drainage of pancreatic necrosis;Endoscopic debridement for pancreatic necrosis;Vascular interventional therapy;ICU stay;Length of hospital stay, days;Hospital costs;New-onset bleeding;Rebound of serum TG;Drugs-related adverse events;

Secondary

MeasureTime frame
New-onset organ failure;Mortality;Time to achieve the TG goal of < 5·65 mmol/L, days;systemic inflammatory response syndrome (SIRS);Necrotizing pancreatitis;Infected pancreatic necrosis;Sepsis;Pulmonary infection;Pseudoaneurysm;

Countries

China

Contacts

Public ContactNonghua Lv

The First Affiliated Hospital of Nanchang University

lunonghua@ncu.edu.cn+86 791 8869 2705

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026