EUCTR2015-000849-23-NL进行中（未招募）1 期
A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSION - The HOME Study (HPN WITH OMEGA-3)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent available
- •2. Male or female patients = 18 years of age
- •3. Patients with chronic intestinal failure receiving HPN including lipids in whom
- •the parenteral macronutrients have not been changed by more than 10% for
- •at least 3 months
- •4. Patients receiving = 3.0 g lipids/kg body weight per week
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Persistent high total bilirubin values in medical history of the last 6 months
- •(> 40µmol/l)
- •2. Patients in whom PN was interrupted for longer than 4 continuous weeks in
- •the preceding 6 months
- •3. Patients with history of cancer and anti-cancer treatment within the last
- •4. Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active
- •substances or excipients
- •5. Patients treated in the past or currently with Teduglutide
- •6. Contraindications to investigational products (if available from medical
- •records) including:
- •- Severe hyperlipidemia, including severe hypertriglyceridaemia (= 1000
- •mg/dl or 11.4 mmol/l)
- •- Severe coagulopathy
- •- Intrahepatic cholestasis
- •- Severe hepatic insufficiency
- •- Severe renal insufficiency in absence of renal replacement therapy
- •- Acute thromboembolic events
- •- Fat embolism
- •- Aggravating haemorrhagic diatheses
- •- Metabolic acidosis
- •7. General contraindications to parenteral nutrition (if available from medical
- •records) including:
- •- Unstable circulatory status with vital threat (states of collapse and shock)
- •- Acute phase of cardiac infarction or stroke
- •- Unstable metabolic conditions (e.g. decompensated diabetes mellitus,
- •severe sepsis, coma of unknown origin)
- •- Inadequate cellular oxygen supply
- •- Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and
- •hypotonic dehydration)
- •- Acute pulmonary edema
- •- Decompensated cardiac insufficiency
- •8. Positive test for HIV, Hepatitis B or C (from medical history)
- •9. Known or suspected drug or alcohol abuse
- •10. Patients who are unwilling or mentally and/or physically unable to adhere to
- •study procedures
- •11. Participation in another interventional clinical trial in parallel or within three
- •months prior to the start of this clinical trial
- •12. Any medical condition that in the opinion of the investigator might put the
- •subject at risk or interfere with patients participation
- •For women with childbearing potential (i.e. females who are not chemically or
- •surgically sterile or females who are not post-menopausal)
- •13. Women of childbearing potential tested positive on standard pregnancy test
- •(urine dipstick)
- •14. Lactation
- •15. Women of childbearing potential who do not agree to apply adequate
- •contraception
- •16. Persons of legal age who are the subject of a legal protection
- •measure or who are unable to express their consent.
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