BIA-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients (BEDTIME)

Mahidol University

Status: Completed

Conditions: Renal Failure Chronic Requiring Hemodialysis; Poor Quality Sleep

Treatments: Device: BIA

Study type: Interventional

Funder types: Other

Identifiers

NCT02825589

ID05-59-12

Details and patient eligibility

About

Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead to sleep apnea and poor sleep quality. The investigators conduct this trial to evaluate whether more accurate dry weight assessment with BIA in these patients can lead to better sleep quality (measured by sleep actigraphy and questionnaires). The investigators will enroll 30 chronic hemodialysis patients in hemodialysis unit of Ramathibodi hospital whose age > 18 years with subclinical hypervolemic status and baseline Pittsburgh sleep quality index (PSQI) score > 5 into study. Patients with bed-ridden status, alteration of consciousness and unstable hemodynamics will be excluded. Then eligible patients will be randomized into 2 groups, BIA-guided and standard clinical guided dry weight assessment. The investigators will assess participants' dry weight at beginning of study, 3rd month and 6th month. Sleep actigraphy parameters (eg. total sleep time, sleep efficiency), sleep questionnaires score, left ventricular mass index by echocardiography, ambulatory blood pressure monitoring and blood chemistry results were collected at beginning of study, the end of 1st, 3rd and 6th month. The primary outcome is change of sleep actigraphy parameters between the groups. The secondary outcomes are change of sleep questionnaires scores, change of left ventricular mass index, change of ambulatory BP monitoring and also cardiovascular complications between groups.

Full description

This randomized control trial aim to detect the better volume control guided by bioimpedance may improve ambulatory blood pressure control, sleep quality and left ventricular hypertrophy.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• regular hemodialysis 3 times/week
• PSQI score >5
• Subclinical hypervolemia

Exclusion criteria

• bed ridden status
• alteration of consciousness
• unstable hemodynamics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

BIA-guided

Experimental group

Description:

Assessment of target dry weight guided by using bioelectrical impedance analysis (BIA).

Treatment:

Device: BIA

Standard clinical guided

No Intervention group

Description:

Assessment of target dry weight guided by clinical evaluation eg. jugular venous pressure, blood pressure, edema etc.