Preventing Nephropathy Induced by Iodinated Contrast Media in Patients With Renal Impairment: a Randomized Trial Evaluating the Effectiveness of Two Hydration Strategies and L-carnitine Administration
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Change in glomerular filtration rate
研究概览
简要总结
The general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. The study focuses on two main factors that may influence acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral L-carnitine treatment. We will also test for a potential interaction between these two factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
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 patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is scheduled for a coronarography
- •The patient can come back to the hospital on days 2 and 7 after the coronarography for follow up
- •The patient has moderate to severe renal insufficiency (glomerular filtration rate < 60 ml / min / 1.73 m^2)
- •The patient has not had any oral antidiabetic treatments, or diuretic treatments, within 48 hours preceding the coronarography
- •Lack of treatment with ACE inhibitors or ARA2 24 hours prior to coronary
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by another study
- •The patient is under judicial protection
- •The patient is under any kind of guardianship
- •The patient refuses to sign the consent form
- •It is impossible to correctly inform the patient
- •The patient is unable to participate in follow-up visits at days 2 and 7 after the coronarography
- •The patient is pregnant or breastfeeding
- •The patient is taking L-carnitine
- •The patient has a contra indication for a treatment used in this study
- •Acute heart failure
- •Infarction, acute phase
- •Hemodialysis patient
- •Epileptic patient treated with Depakine (valproic acid) (carnitine can lower epilepsy-related thresholds by speeding up the metabolism of Depakine)
研究组 & 干预措施
Bicarbonate
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate.
Intervention: Hydration strategy using sodium bicarbonate Intervention: Coronarography
干预措施: Hydration strategy using sodium bicarbonate (Drug)
Bicarbonate
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate.
Intervention: Hydration strategy using sodium bicarbonate Intervention: Coronarography
干预措施: Coronarography (Procedure)
Saline
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution.
Intervention: Hydration strategy using saline Intervention: Coronarography
干预措施: Hydration strategy using saline (Drug)
Saline
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution.
Intervention: Hydration strategy using saline Intervention: Coronarography
干预措施: Coronarography (Procedure)
Bicar + L-Carnitine
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using sodium bicarbonate Intervention: L-carnitine Intervention: Coronarography
干预措施: Hydration strategy using sodium bicarbonate (Drug)
Bicar + L-Carnitine
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using sodium bicarbonate Intervention: L-carnitine Intervention: Coronarography
干预措施: L-carnitine (Drug)
Bicar + L-Carnitine
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy containing sodium bicarbonate. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using sodium bicarbonate Intervention: L-carnitine Intervention: Coronarography
干预措施: Coronarography (Procedure)
Saline + L-carnitine
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using saline Intervention: L-carnitine Intervention: Coronarography
干预措施: Hydration strategy using saline (Drug)
Saline + L-carnitine
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using saline Intervention: L-carnitine Intervention: Coronarography
干预措施: L-carnitine (Drug)
Saline + L-carnitine
The patients included in this arm will be administered a hydration regime for the prevention of contrast-induced nephropathy using sodium chloride solution. They will also receive an oral L-carnitine solution on days -1, 0, 1 to 7.
Intervention: Hydration strategy using saline Intervention: L-carnitine Intervention: Coronarography
干预措施: Coronarography (Procedure)
结局指标
主要结局
Change in glomerular filtration rate
时间窗: baseline versus 48 hours after contrast injection
The change in MDRD glomerular filtration rate before coronarography, and 48 hours after the injection of contrast material.
次要结局
- % Change in creatinemia(baseline versus Day 7)
- Quantity of contrast material injected / glomerular filtration rate(Day 0 - just after coronarography)
- Change in creatinemia(baseline versus Day 7)
- Hemodialysis necessary?(Day 7)
- Mortality(Day 7)
- Contrast induced nephropathy?(Day 7)
- Change in glomerular filtration rate compared to baseline(baseline versus Day 7)
- Quantity of iodine injected / glomerular filtration rate(Day 0, just after coronarography)
- Change in serum ngal(baseline (just before coronarography) versus 4 hours after contrast injection)