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Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease

NCT02390193 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-06-15

No results posted yet for this study

Summary

Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public health problems, becoming a global epidemic. It is also known that the amount of displacement of overnight rostral fluid, from the lower limbs, is related to increased neck circumference and severity of obstructive sleep apnea (OSA) in patients with end-stage renal disease. Method / Design: A clinical trial study aiming to assess the degree of collapsibility of the upper airway in patients with CKD undergoing hemodialysis has been proposed. The test of the negative expiratory pressure and nocturnal polysomnography will be performed before and after the hemodialysis session. Discussion: The incidence of CKD has increased, due to the increased number of cases of diabetes mellitus and hypertension. Our hypothesis is that the weight gain due to volume overload, observed in the interdialytic period, will exert a negative influence on the degree of collapsibility of the upper airways predispose to OSA in CKD patients.

Conditions

  • Renal Insufficiency, Chronic

Interventions

PROCEDURE

Hemodialysis

Daytime haemodialysis was standardised. It was performed 3 times per week, with a 4-h session duration, 250-mL/min blood flow, and 500-mL/min dialysate flow, using bicarbonate buffered dialysate with 1.25 mmol/L ionised calcium concentration, dialysate temperature of 36.5°C. The ultrafiltration amount for each haemodialysis session was decided by individual dry weight, which was fixed during the trial. In addition, the patients were not permitted to change their medication or start new drugs, especially antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, and β-blockers. The patients who required a change in medication for medical reasons were subsequently excluded from the study.

Sponsors & Collaborators

  • Irmandade da Santa Casa de Misericordia de Sao Paulo

    collaborator OTHER

  • Centro Universitário de Anapolis

    lead OTHER

Principal Investigators

  • Luis VF Oliveira, PhD · Centro Universitário de Anápolis - UniEVANGÉLICA

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-02
Primary Completion
2018-05-02
Completion
2020-12-03

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02390193 on ClinicalTrials.gov