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Effect of aggressive fluid control on sleep apnea and cardiovascular outcomes in peritoneal dialysis with moderate to severe OSA

Effect of aggressive fluid control on sleep apnea and cardiovascular outcomes in peritoneal dialysis with moderate to severe OSA

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230601006
Enrollment
200
Registered
2023-06-01
Start date
2023-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea in Peritoneal Dialysis Peritoneal Dialysis OSA

Interventions

The aggressive fluid control intervention in the FLUID-INTENSIVE TRIAL consists of three novel components: 1. The use of bioelectrical impedance analysis (BIA) in addition to clinical assessment for b
s worth noting that aggressive fluid management requires clos
Experimental Behavioral,No Intervention No treatment
Aggressive Fluid Control,Standard of Care

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
AHI 3 months Full night sleep test

Secondary

MeasureTime frame
All-cause mortality 3 months chart review, interview,All-cause mortality 12 months chart review, interview

Countries

Thailand

Contacts

Public ContactSeelwan Sathitratanacheewin

Faculty of medicine, Chulalongkorn university

seelwan@docchula.com0982954203

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026