Home-based Ultrafiltration for Congestive Heart Failure: Impact on Survival, Hospitalizations Rate, Quality of Life, Peritoneal Membrane Characteristics and Residual Renal Function With Different Treatment Modes
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The purpose of this study is to determine whether the treatment of peritoneal ultrafiltration can improve survival and quality of life of refractory congestive heart failure with special accent on preserving residual renal function and peritoneal membrane characteristics/
详细描述
Congestive heart failure (CHF) is the leading cause of acute hospital admissions. The morbidity associated with this condition presents a major health and economic challenge, which is anticipated to increase in the aging of population especially in developed countries.
Peritoneal dialysis (PD) in patients with diuretic resistant cardio-renal syndrome type 2 enables low-molecular weight solute clearance and ultrafiltration (UF) without serious hemodynamic changes, which makes this modality attractive for chronic CHF treatment . The key practical advantage of PD is that the patient can be treated at home, with treatment adjustment in accordance with his current condition. The additional advantages are: continuous UF, flexible schedule, no need for devices or anticoagulation, no need for medical staff.
Despite the fact that there was no significant improvement of survival in CHF patients treated by PD, as compared to regular treatment, improvement of symptoms, physical performance, quality of life , biochemical profile, and significant decrease in hospitalization rate have been reported.
PD has a number of both theoretical and practical advantages for extending treatment in CHF patients, but there is little experience in this field and limited knowledge regarding its influence on peritoneal membrane and renal function in patients with moderate renal failure.
Aims of the study:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •diagnosis of heart failure NYHA 3-4 on maximal treatment with evidence of diuretic resistance and repeated hospital admissions due to fluid overload (at least 2 in previous 3 months)
- •evidence of CKD stage 3-4
- •agreement to place dialysis catheter in the peritoneal cavity for PD treatment or IV access for hemodialysis
- •available medical records 1 year before dialysis treatment
排除标准
- •unstable hemodynamic or respiratory condition
- •need for vasopressor support
- •patient refusal
- •lack of family support or housing conditions needed for PD treatment
- •evidence of active kidney disease (obstructive uropathy, glomerulonephritis, vasculitis etc.) at recruitment to the study
- •contraindications for peritoneal ultrafiltration treatment (active intraabdominal or abdominal wall inflammatory process, morbid obesity, multiple abdominal surgery in the past)
- •non compliance with treatment protocol
结局指标
主要结局
all cause mortality
时间窗: 1 year
次要结局
- decrease in urine volume(1 year)
- hospitalization for uncompensated heart failure(1 year)
- ultrafiltration changes required change in peritoneal fluid prescription(1 year)
- deterioration of renal function (every increasing in CKD stage)(1 year)
- complications, necessitating peritoneal catheter or hemodialysis catheter(1 year)