TCTR20230601006尚未招募2 期
Effect of aggressive fluid control on sleep apnea and cardiovascular outcomes in peritoneal dialysis with moderate to severe OSA
/A0 个研究点目标入组 200 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •To be eligible for entry into the study, patients must satisfy the following criterias:
- •-New or incumbent peritoneal dialysis patients, more than 18 to less than 80 years of age.
- •-Patients have moderate-severe OSA (equivalent to apnea plus hypopneas index [AHI] more than 20 per hour of sleep) confirmed by the central sleep laboratory at King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
- •-Patients are able and willing to give appropriate informed consent.
排除标准
- •Patients will be excluded from entry if ANY of the criteria listed below are met
- •1.Morbid Obesity with BMI more than 35.0
- •2.Recent diagnosis of stroke, cognitive dysfunction or neuromuscular disease with bulbar or respiratory system involvement; recent stroke within 12 weeks (about 3 months);
- •a.previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral haemorrhage) within 90 days prior to informed consent; or
- •b.previous transient ischaemic event (TIA) of the brain or retina (symptoms less 24 hours) with
- •the diagnosis confirmed by a neurologist within 30 days prior to informed consent.
- •c.significant memory, perceptual, or behavioural disorder
- •d.neurological deficit (e.g., limb paresis)
- •3.Severe respiratory disease:
- •a.Severe COPD (FEV1/FVC less than 70% and FEV1 less than 50% predicted)
- •b.Pulmonary arterial hypertension
- •c.Resting, awake SaO2 less than 90%
- •d.Severe nocturnal desaturation more than 10% overnight recording time with arterial oxygen saturation of less than 80%
- •e.Cheyne-stokes respiration (CSResp)
- •4.Prior use of CPAP treatment for OSA
- •5.Technical problems with peritoneal dialysis: TK malposition, recent PD associated infection within 30 days
- •6.Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example,
- •a.residence sufficiently remote from the clinic to preclude follow-up clinic visits.
- •b.co-morbid disease with severe disability or likelihood of death within the next 2 years
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