Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 18
- 主要终点
- Extracellular compartment M3
研究概览
简要总结
Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be useful. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure. No prospective data has been published in clinical routine. Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. The principal criterion of evaluation will be the variation in the extracellular compartment.
详细描述
Metabolic acidosis recovers a wide range of diseases - chronic kidney diseases, nephrolithiasis, or others - in which an oral alkalinization could be useful. Oral alkalinization could be performed or by bicarbonate contained in alkaline-based waters or drug therapies or by citrate. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure, especially due to the amount of daily sodium load. No prospective data has been published in clinical routine, studying its effects on extracellular volume nor the blood pressure control.
Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. Initial recorded data will be: age, gender, prescription (indication, kind of alkali therapy, volume and duration), body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, comorbidities, drug therapy, blood and urine composition. The recorded follow-up will be: the adherence to treatment, body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, adverse events, blood and urine composition.
The principal criterion of evaluation will be the variation in the extracellular compartment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •> or = to 18 years old
- •in whom an oral alkalinization is indicated
排除标准
- •if the patient mentions its opposition to his/her enrollment
研究组 & 干预措施
Alkali
Patients in whom an oral alkalinization whatever the formulation
干预措施: Alkali (Drug)
结局指标
主要结局
Extracellular compartment M3
时间窗: At M3 (month 3)
Evaluation of the extracellular compartment by a composite clinical outcome at M3 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema
次要结局
- Urine chloride (mmol/d)(At M3 (month 3))
- Proteinuria (g/d)(At M3 (month 3))
- Proteinemia (g/l)(At M3 (month 3))
- Albuminemia (g/l)(At M3 (month 3))
- Natremia (mM)(At M3 (month 3))
- Urine output (l/d)(At M3 (month 3))
- Extracellular compartment M6(At M6 (month 6))
- Kalemia (mM)(At M3 (month 3))
- Bicarbonatemia (mM)(At M3 (month 3))
- Natriuresis (mmol/d)(At M3 (month 3))
- Blood chloride (mM)(At M3 (month 3))
- Creatininemia (microM)(At M3 (month 3))
- Creatinuria (mmol/d)(At M3 (month 3))
研究者
Jean-Philippe Bertocchio
President, Investigator
Club des Jeunes Néphrologues