2023-510406-41-00招募中2 期
CLEARTOX: Development of an innovative haemodialysis method to improve dialytic clearance of protein-bound uraemic toxins
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Clearance of p-Cresyl sulfate during hemodialysis. Dialysis clearance is defined as follows: Clairance = Qd X (C dialysate/C arterial) Calculated over 240 minutes with Qd corresponding to dialysate flow rate, C dialysate uremic toxin concentration in dialysate, C arterial uremic toxin concentration in blood taken from the arterial port of the dialyzer.
研究概览
简要总结
Compare the clearance of p-cresyl sulfate during dialysis (from H0 to H4) between a hemodialysis session with infusion of a medium-chain fatty acid emulsion (Medialipide®) and a hemodialysis session with infusion of saline.
研究设计
- 分配方式
- Randomized
- 主要目的
- Medialipide
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •On hemodialysis at a frequency of 3 4-hour sessions per week, for at least 3 months
- •For patients of childbearing potential, highly effective contraception (e.g. total sexual abstinence, combined hormonal contraception, bilateral tubal obstruction, etc.) is required for the entire duration of treatment. A blood pregnancy test (beta-HCG) will be performed at inclusion.
- •Patient affiliated to a social security scheme
- •Free, informed and written consent signed by the patient
排除标准
- •Residual diuresis > 100 mL per day
- •Patients with unstable metabolic conditions (e.g. severe post-traumatic syndrome, coma of unknown origin)
- •Patients in the acute phase of myocardial infarction or stroke
- •Pregnant or breastfeeding
- •Patients with uncorrected disturbances of fluid and electrolyte balance, such as hypokalemia and hypotonic dehydration
- •Patients with decompensated heart failure
- •patients with acute pulmonary edema
- •Subject having participated in another interventional research study in the 30 days prior to inclusion in the study or still within 5 half-lives of the experimental product of a previous interventional research study.
- •Uncontrolled hypertension > 180/115 mmHg
- •Perdialytic hypotension requiring vascular filling > 100 mL during the last 3 sessions
- •Patient already on parenteral nutrition
- •Patients with sepsis < 1 month
- •Patient already on antivitamin K (or prescribed less than one month prior to inclusion)
- •Patient with heparin allergy or requiring hemodialysis without anticoagulant (recent hemorrhage)
- •Patients allergic to egg, soy or peanut proteins or to any of the active ingredients or excipients (glycerol, egg phospholipids for injection, a-tocopherol, sodium oleate (for pH adjustment), water for injection) of Médialipide®
- •Patients with severe hyperlipidemia or severe lipid metabolism disorders characterized by hypertriglyceridemia > 3 mmol/l
- •Patients on non-steroidal anti-inflammatory drugs
- •Patients under legal protection
- •Persons incapable of expressing their consent
- •Persons deprived of their liberty and emergency situations.
- •Patient with severe liver failure or cholestasis
- •Patient with known severe coagulopathy
- •Patient with acute thromboembolic events
- •Patient with fat embolism
- •Patient with an aggravating bleeding diathesis
- •Patient with uncompensated metabolic acidosis
- •Patient with an unstable circulatory state threatening the vital prognosis (collapse and shock)
结局指标
主要结局
Clearance of p-Cresyl sulfate during hemodialysis. Dialysis clearance is defined as follows: Clairance = Qd X (C dialysate/C arterial) Calculated over 240 minutes with Qd corresponding to dialysate flow rate, C dialysate uremic toxin concentration in dialysate, C arterial uremic toxin concentration in blood taken from the arterial port of the dialyzer.
Clearance of p-Cresyl sulfate during hemodialysis. Dialysis clearance is defined as follows: Clairance = Qd X (C dialysate/C arterial) Calculated over 240 minutes with Qd corresponding to dialysate flow rate, C dialysate uremic toxin concentration in dialysate, C arterial uremic toxin concentration in blood taken from the arterial port of the dialyzer.
次要结局
- The fraction of p-CS reduction during the hemodialysis session. The reduction fraction (RF) will be calculated according to the formula: RF (%) = ( Concentration (t=0 min) - Concentration (t=240 min ))/Concentration (t= 0 min)
- Clearance and reduction fraction (over 240 minutes) of other protein-bound uremic toxins during the hemodialysis session: indoxyl sulfate, hippuric acid, p-cresyl glucuronide, 3-indole acetic acid, uric acid and 3-carboxy-4-methyl-5propyl-furanpro-pionic acid.
- Tolerance: % of patients with at least one of the following adverse events: nausea, vomiting or headache during the session.
- Safety: % of patients with one of the following events: triglyceridemia > 4 g/L or 4.6 mmol/L at the end of the session, alteration in liver balance (ALT, ASAT, gamma GT, PAL, free and conjugated bilirubin) or significant hemolysis during follow-up.
- Comparison of plasma concentration of medium-chain fatty acids (octanoate and decanoate) between start and end of infusion.
研究者
Pr Fitsum-Guebre EGZIABHER
Scientific
Hospices Civils De Lyon
研究点 (1)
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