Diuretic/Cool Dialysate Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Slow the Rate of Residual Renal Function (RRF)
研究概览
简要总结
The proposed pilot study challenges the current widespread paradigm of discontinuing loop diuretics when initiating chronic HD and/or maintaining the dialysate at a constant temperature of 37 °C for all patients.
详细描述
This pilot/feasibility RCT will recruit for 18 months and demonstrate the feasibility and safety of performing a large scale study of diuretic use and/or cool dialysate examining recruitment, retention, and key outcomes. This study will further assess whether the use of a diuretic compared to non-use of a diuretic and/or the use of cool dialysate (35.5 ºC) compared to 37 ºC for up to 6 months will improve residual renal function (RRF), improve health reported quality of life (HRQOL) and reduce hospitalizations by randomizing 20 dialysis-naïve patients (started chronic HD in the last three months) from DCI centers in the greater Albuquerque area, to either bumetanide and cool dialysate randomized in a two-by-two factorial distribution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Primary speaking language is English.
- •Patient is HD naïve (Patient may still enroll as long as no more than 12 weeks of in-center HD have been performed prior to randomization)
- •HD takes place at one of the participating Dialysis Clinic Inc. (DCI) sites during the data collection period.
- •Daily urine output is over 500ml.
- •Patients must be willing and able to sign the consent form.
排除标准
- •RRF <5 mL/min/1.73 m2 as determined by iohexol GFR measurement.
- •Allergy or contraindication to iohexol and/or bumetanide.
- •Has been undergoing dialysis for more than 12 weeks.
- •Expectation that native kidneys will recover.
- •History of poor adherence to treatment.
- •Unable to verbally communicate in English.
- •Requires more than 3 HD treatments per week due to medical co-morbidity (such as, but not limited to: severe volume overload requiring frequent HD e.g. in systemic oxalosis, or requiring total parenteral nutrition).
- •Scheduled for living donor kidney transplant in the next 6 months.
- •Intention to change to peritoneal dialysis, or home HD in the next 6 months.
- •Plan to relocate to another center within the next 7-8 months.
- •Expected geographic unavailability at a participating HD unit for >2 consecutive weeks or >4 weeks total during the next 6 months (excluding unavailability due to hospitalizations)
- •Post kidney transplantation
- •Currently in an acute or chronic care hospital
- •Life expectancy <6 months or intention to withdraw dialysis therapy within 6 months.
- •Current pregnancy
- •Actively planning to become pregnant in the next 8 months
- •Nursing mothers
- •Current use of investigational drugs
- •Participation in another non-observational clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
- •Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
- •Unable or unwilling to provide informed consent or sign IRB-approved consent form.
- •The following special populations will not be included in this study:
- •Patients who are too infirm or lack the capacity to meaningfully participate in medical decisions and to sign the informed consent.
- •Children and adolescents constitute <2% of the dialysis population, and our preliminary survey of the study sites found no children and adolescents were active patients. In any case, the renal and other physical factors of children and adolescents with ESRD are not directly comparable to those of adults.
- •Prisoners.
研究组 & 干预措施
No Diuretic and 35.5°C dialysate
Cool dialysate only, no diuretic
干预措施: Cool Dialysate (Other)
Diuretic and 37°C dialysate
Isothermic dialysate (37°C) and bumetanide (diuretic)
干预措施: Bumetanide (Drug)
Diuretic and 35.5°C dialysate
Cool dialysate (35.5°C) and bumetanide (diuretic)
干预措施: Bumetanide (Drug)
Diuretic and 35.5°C dialysate
Cool dialysate (35.5°C) and bumetanide (diuretic)
干预措施: Cool Dialysate (Other)
结局指标
主要结局
Slow the Rate of Residual Renal Function (RRF)
时间窗: 6 months
To be randomized Adequate RRF has to be determined in the first 24 hour collection (ml/min). If randomized RRF will be collected day 0 pre-dose intervention and Month 4 and 6 of intervention (3 collections) to determine if the rate was slowed. RRF is standard of care assessment for patients on dialysis for quality of life and survival.
次要结局
未报告次要终点
研究者
Mark Unruh
Department of Internal Medicine, Division of Nephrology Chief
University of New Mexico