Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
Słowa kluczowe
Abstrakcyjny
Opis
Hypertriglyceridemia-induced acute pancreatitis occurs in about 1-4% of the cases. It is the third leading cause of pancreatitis after biliary and alcoholic etiology. Hypertriglyceridemia can be caused by primary causes, lipid metabolism disorders and secondary causes.
Hyperlipidemic pancreatitis can be provoked when triglyceride levels (TGL) exceed 11.3 mmol/l (1,000 mg/dl). Except for standard symptomatic treatment, plasmapheresis and insulin have been performed to rapidly reduce TGL and chylomicron levels in the blood.The therapeutic efficacy of intensive insulin, standard insulin, and plasmapheresis in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.After acceptance patients will be randomized by random envelope in the 3 groups: Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.
Daktyle
| Ostatnia weryfikacja: | 05/31/2018 |
| Pierwsze przesłane: | 03/28/2018 |
| Szacowana liczba przesłanych rejestracji: | 04/09/2018 |
| Wysłany pierwszy: | 04/17/2018 |
| Ostatnia aktualizacja przesłana: | 06/03/2018 |
| Ostatnia opublikowana aktualizacja: | 06/05/2018 |
| Rzeczywista data rozpoczęcia badania: | 06/05/2018 |
| Szacowana data zakończenia podstawowej działalności: | 03/07/2020 |
| Szacowana data zakończenia badania: | 12/30/2020 |
Stan lub choroba
Interwencja / leczenie
Drug: Insulin
Device: Group C: plasmapheresis
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: Group A: intensive insulin Group A: intensive insulin (glycemic control 4.4-6.1mmol/L) | |
| Active Comparator: Group B: standard insulin Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), | |
| Active Comparator: Group C: plasmapheresis Group C: plasmapheresis | Device: Group C: plasmapheresis Triglyceridemia should be less than 5.65 mmol/l. |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - Diagnosis of hypertriglyceridemia induced acute pancreatitis (AP): Typical pain increase in serum lipase or amylase with serum TG> 1,000 mg/dL (11.3mmol/L) or serum was milky with serum TG> 500 mg/dL(5.65 mmol/L) - Onset of abdominal pain within <=48h before admission - moderate severe or severe Acute Pancreatitis according to Atlanta criteria - except for other AP causes, such as cholelithiasis, alcohol, drugs and so on Exclusion Criteria: - other etiologies other than hyperlipidemia leading to AP - at the same time combined with other etiologies of AP - appear difficult to reverse respiratory failure, severe systemic circulatory failure, coma and other the endangered symptoms, patients expected to die within 24hours - disseminated intravascular coagulation, or patients with severe active bleeding - without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias. |
Wynik
Podstawowe miary wyników
1. Reduction of mortality [From admition to hospital discharge, an average of 2 months]
2. Reduction of organ failure [From admition to hospital discharge, an average of 2 months]
3. triglyceride levels [From admition to hospital discharge, an average of 2 months]
Miary wyników wtórnych
1. cytokines in serum, urine [From admition to 7 days]
2. insulin dose [From admition to 7 days]
3. Severity Score in CT scan [From admition to 7 days]
4. TNF-α in serum, urine [From admition to 7 days]
5. Clinical Severity Score [From admition to 7 days]
Inne miary wyników
1. Genomics [From admition to 7 days]
2. Clinical Severity Score [From admition to 7 days]
3. Clinical Severity Score [From admition to 7 days]
