Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 05/31/2018 |
| Прво доставено: | 03/28/2018 |
| Поднесено е проценето запишување: | 04/09/2018 |
| Прво објавено: | 04/17/2018 |
| Последното ажурирање е доставено: | 06/03/2018 |
| Последно ажурирање објавено: | 06/05/2018 |
| Крај на датумот на започнување на студијата: | 06/05/2018 |
| Проценет датум на примарно завршување: | 03/07/2020 |
| Проценет датум на завршување на студијата: | 12/30/2020 |
Состојба или болест
Интервенција / третман
Drug: Insulin
Device: Group C: plasmapheresis
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| 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. |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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. |
Исход
Мерки на примарниот исход
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]
Секундарни мерки на исходот
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]
Други мерки на исход
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]
