Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
Клучни зборови
Апстракт
Опис
The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, which is defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy. Patients with clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion) will be excluded. The investigators will also exclude patients who are in overt pulmonary edema and required urgent medical care, who have cognitive impairment or problem of communication, unlikely to survive for more than three months, have mechanical problems of the dialysis catheter, or have active peritonitis or peritoneal failure.
Датуми
| Последен пат проверено: | 01/31/2020 |
| Прво доставено: | 06/17/2014 |
| Поднесено е проценето запишување: | 06/17/2014 |
| Прво објавено: | 06/19/2014 |
| Последното ажурирање е доставено: | 02/11/2020 |
| Последно ажурирање објавено: | 02/16/2020 |
| Крај на датумот на започнување на студијата: | 11/30/2015 |
| Проценет датум на примарно завршување: | 08/31/2017 |
| Проценет датум на завршување на студијата: | 08/31/2018 |
Состојба или болест
Интервенција / третман
Combination Product: treatment arm
Behavioral: Control arm
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Experimental: treatment arm active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen | Combination Product: treatment arm Hypertonic peritoneal dialysis cycles |
| Active Comparator: control arm dietary counseling alone |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: - asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy Exclusion Criteria: - clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion) - overt pulmonary edema and required urgent medical care - cognitive impairment or problem of communication - unlikely to survive for more than three months - mechanical problems of the dialysis catheter - active peritonitis or peritoneal failure |
Исход
Мерки на примарниот исход
1. blood pressure control [1 year]
2. number of antihypertensive medications [1 year]
3. duration of hospitalization for all cause [1 year]
4. hospitalization for cardiovascular disease [1 year]
Секундарни мерки на исходот
1. degree of overhydration [1 year]
2. change in residual GFR [1 year]
3. nutritional status [1 year]
4. arterial pulse wave velocity [1 year]
5. cardiovascular mortality [1 year]
6. all-cause mortality [1 year]
Други мерки на исход
1. cause of hospital admission [1 year]
