Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cardiac Output
研究概览
简要总结
The goal of this study is to evaluate interdialytic blood pressure changes of the patients in chronic hemodialysis.
The main question to be answered is: What is the relative importance of weight gain, the renin angiotensin system, the sympathetic nervous system and inflammatory immune reactivity in the interdialytic hypertension of patients in chronic hemodialysis, The participants will have hemodynamic evaluation (cardiac output and peripheral vascular resistance) at the end of dialysis, ambulatory monitoring of blood pressure in the interdialytic period. Serum samples will be collected at the end of dialysis and before the start of the next dialysis, 2-3 days later.
详细描述
This is a prospective observational study that will study stable patients in the chronic hemodialysis program of the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" (INCMNSZ) patients. There will be no modifications in the dialysis prescriptions or treatments and the patients with inclusion criteria will be studied after and before their usual hemodialysis sesion.
- Weight changes will be studied after dialysis and before the next dialysis session (2-3 days later)
- Serum samples will be obtained at the end of dialysis and before the next session (2-3 days later).
- ultrasound estimation of cardiac output and peripheral vascular rersistance will be done after dialysis
- Ambulatory blood pressure (ABP) monitoring will be done in the interdialytic period (24-40 hours) between the end of dialysis and the next dialysis session.
- If possible there will be a predialysis study of bioimpedance.
- Associations of interdialytic weight gain, serum angiotensin II, copeptin levels (surrogate of arginine vasopressin) and norepinephrine levels with ABP, systolic and diastolic blood pressure before and after dialysis will be explored.
- Phenotypes of blood pressure (sustained hypertension, nocturnal and diurnal hypertension, dippers, non-dippers, extreme dippers and reverse dippers) determined by ambulatory monitoring will be studied in relation of levels of angiotensin II, inflammatory markers, copeptin and norepinephrine levels.
All serum levels will be determined by commercial ELISA kits
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients with more than 3 months in the chronic hemodialysis program in the INCMNSZ and assumed to remained in the program for longer than 3 months
- •Stable patients with no change in medication 1 month prior to the study
- •Unchanged drug therapy and dialysis prescription for >1 month prior to the studies
- •Informed consent to participate in the study
排除标准
- •Patients unable to give informed consent or withdrawal of informed consent to the study
- •Patients with active infection
- •Patients with prosthesis or pacemakers
- •Patients with immunosuppressive treatment of more than 10mg Prednisone daily
- •Prior nephrectomy
- •incomplete collection of data specified in the study protocol
研究组 & 干预措施
Group A
There will be no intervention. Group A will be patients with ABP (ambulatory blood pressure) <130/80 mmHg (controlled hypertension)
干预措施: There will be no intervention (Other)
Group B
There will be no intervention. Group B will be patients with ABP 130-139/80-89 mmHg (insufficiently controled hypertension)
干预措施: There will be no intervention (Other)
Group C
There will be no intervention. Group C will be patients with ABP ≥140/90 mmHg (uncontrolled hypertension)
干预措施: There will be no intervention (Other)
结局指标
主要结局
Cardiac Output
时间窗: Each participant was studied once 1-3 hours after dialysis ended
Cardiac output (systolic volume x heart rate) was determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
Interdialytic Weight Change
时间窗: Interdialytic weight change was studied once, by the difference between the weight at the end of dialysis and the weight 2-3 days later, before the next dialysis.
The weight was determined in 2 ocassions: first, immediately after dialysis and second, 2-3 days later, before the next dialysis. The weight change in this interval is expressed as percentage change of the second measure in relation to the first measure.
Systemic Vascular Resistance
时间窗: Systemic vascular resistance was determined once in the participants 1-3 hours after dialysis
Systemic vascular resistance was calculated using MediCalcR using the mean arterial pressure (MAP), the central venous pressure (CVP) anf the cardiac output (CO) and the equation: SVR=\[(MAP-CVP)x79.92\]/CO. Cardiac output (CO= systolic volume x heart rate) and central venous pressure were determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer. Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
次要结局
- Angiotensin II Serum Levels(Each participant was studied once. Serum samples taken before dialysis)
- Monocyte+Neutrophiles/Lymphocyte Ratio (MNLR)(Each participant was studied once. Blood samples taken before dialysis (following the end of the interdialytic period).)
- Serum Norepinephrine Levels(Each participant was studied once. Serum samples taken before dialysis)
- Serum Copeptin Levels(Each participant was studied once. Serum samples taken before dialysis)
- Hypertension Phenotypes(Each participant was studied once. Ambulatory blood pressure was monitored or 24-44 hours during the interdialytic perdiod starting 1-3 hours after dialysis)
研究者
Bernardo Rodríguez Iturbe
Researcher
National Institute of Medical Sciences and Nutrition, Salvador Zubiran