L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury: a Multicentre, Randomized, 2-parallel Group, Superiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 254
- 试验地点
- 11
- 主要终点
- Mortality
研究概览
简要总结
The primary objective of this study is to compare 28 day mortality rates between septic shock patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy) versus a similar group of patients not receiving L-Carnitine adjunct therapy.
详细描述
The secondary objectives of this study are:
A. First secondary objective of this study is to compare 10 day mortality rates of septic shock patients with renal insufficiency treated via L-Carnitine (as an adjunct therapy) for 56 days versus a patients not receiving L-Carnitine adjunct therapy
B. To compare study arms in terms of patient safety.
C. To compare study arms in terms of further clinical outcomes, with special emphasis on nephrological outcomes.
D. To study (and compare between arms) the kinetic curves of free and total serum carnitine. Renal replacement therapy rapidly depletes the body's carnitine levels. Tracking adequate carnitine levels is therefore important for the interpretation of study results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is at least 18 years old
- •The patient was admitted to an intensive care unit (participating in the study) for sepsis or septic shock and presented with acute renal failure requiring, at some point, the use of extra-renal purification.
- •• The patient has sepsis or septic shock according to international criteria SEPSIS 3 (Singer et al, The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) ; JAMA. 2016)
- •The patient has acute renal insufficiency with an KDIGO score of 3
- •The patient has started continuous renal replacement therapy (CRRT) or intermittent renal replacement therapy (IRRT) within the previous 72 hours, or will start RRT (CRRT or IRRT) within the next 72 hours.
排除标准
- •• The patient is participating in, or has participated in over the past three months, another interventional study that may interfere with the results or conclusions of this study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, or is an adult under guardianship
- •The patient is pregnant, parturient or breastfeeding
- •The patient is susceptible to procreate and does not use methods of effective contraception (contraceptive hormonal ring, surgical contraception, contraceptive implant, contraceptive pill, male or female sheaths, skin patch, intrauterine contraceptive device)
- •If the patient is unable to sign a consent form: the patient-designated trusted person or family member refuses to sign the consent form
- •If the patient is unable to sign a consent form: It is impossible to correctly inform the patient-designated trusted person or family member
- •The patient is able/apt to sign a consent form, but refuses to do so
- •The patient is able/apt to sign a consent form, but cannot be correctly informed
- •Septic shock without associated AKI
- •Patients with a known allergy to L-Carnitine or other component of levocarnil oral solution or for injection
- •Pre-existing chronic disease requiring dialysis
- •The patient has stage 4 CKD with baseline DFG (CDK) if known <30 ml
- •History of seizures or epilepsy
- •Chronic bowel disease or history of chronic diarrhoea
- •Under treatment with sodium valproate
研究组 & 干预措施
L-Carnitine group
Patients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment.
Intervention: 56 days of weight-adjusted L-Carnitine treatment
干预措施: 56 days of weight-adjusted L-Carnitine treatment (Drug)
Placebo then open group
Patients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards).
Intervention: 10 days of intravenous placebo (isotonic saline)
干预措施: 10 days of intravenous placebo (isotonic saline) (Drug)
结局指标
主要结局
Mortality
时间窗: 28 days
次要结局
- First secondary objective of this study is to compare 10 day mortality rates of septic shock patients with renal insufficiency treated via L-Carnitine (as an adjunct therapy) for 56 days versus a patients not receiving L-Carnitine adjunct therapy.(10 days)
- Adverse Events per patient(12 months (throughout study))
- Survival(12 months (throughout study))
- The number of days alive and not on renal replacement therapy(12 months)
- The number of days alive and free of renal failure(12 months)
- The number of days alive and free of organ failure(12 months)
- The number of days alive and not on mechanical ventilation(12 months)
- The number of days alive and not in Intensive Care Unit (ICU)(12 months)
- The number of days alive and not in hospital(12 months)
- The number of days alive and free of (not requiring) catecholamines(12 months)
- A vector of repeated measures of daily SOFA (Sequential Organ Failure Assessment score) scores available during the ICU stay(at ICU discharge (expected max of 28 days))
- A vector of repeated measures of AKIN (Acute Kidney Injury Network score) score available during the ICU stay(at ICU discharge (expected max of 28 days))
- A vector of repeated measures of serum creatinine(at discharge from the nephrology department (expected max of 60 days))
- A vector of repeated measures of lactate levels available during the ICU stay(at ICU discharge (expected max of 28 days))
- Serum free carnitine level(month 2)
- Serum total carnitine level(month 2)
- Glomerular filtration rate (EpiCKD)(month 12)