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

Primary Purpose

Renal Insufficiency, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hemodialysis
Sponsored by
Centro Universitário de Anapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Insufficiency, Chronic focused on measuring Chronic kidney disease, Dialysis, Sleep, Pulmonary function, Polysomnography, Upper airway

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • male or female patients aged 18 to 80 years;
  • chronic kidney failure;
  • candidate for kidney transplant with indication for dialysis;
  • cognitive level sufficient for understanding the procedures and following the instructions;
  • absence of dementia or treatment-refractory psychiatric diseases leading to an inability to provide informed consent.
  • and agreement to participate by signing a statement of informed consent.

Exclusion Criteria:

  • craniofacial abnormalities;
  • undergoing active treatment of sleep apnea;
  • active malignancy;
  • active alcohol and/or drug abuse;

Sites / Locations

  • Centro Universitário de Anápolis - UniEVANGÉLICARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemodialysis

Arm Description

Chronic kidney disease patients undergoing hemodialysis will be recruited consecutively and screened for eligibility using a standardised protocol.

Outcomes

Primary Outcome Measures

Collapsibility of the upper airway.
Degree of upper airway collapsibility through the negative expiratory pressure test in patients with chronic kidney disease on hemodialysis.

Secondary Outcome Measures

Prevalence and severity of sleep disorders
To assess the effects of dialysis on sleep parameters and determine the prevalence and severity of sleep disorders.
Change in pulmonary function.
Lung function tests will be performed during the day, with the patient seated in a comfortable position. For such, the KoKo PFT Spirometer System version 4.11 (nSpire Health, Inc, Louisville, CO, USA) will be used in accordance with the guidelines for the execution of lung function tests established by the Brazilian Society of Pneumology and European Respiratory Society.

Full Information

First Posted
March 11, 2015
Last Updated
June 13, 2018
Sponsor
Centro Universitário de Anapolis
Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02390193
Brief Title
Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
Official Title
Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2015 (undefined)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
December 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário de Anapolis
Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Chronic kidney disease, Dialysis, Sleep, Pulmonary function, Polysomnography, Upper airway

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemodialysis
Arm Type
Experimental
Arm Description
Chronic kidney disease patients undergoing hemodialysis will be recruited consecutively and screened for eligibility using a standardised protocol.
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Collapsibility of the upper airway.
Description
Degree of upper airway collapsibility through the negative expiratory pressure test in patients with chronic kidney disease on hemodialysis.
Time Frame
06 months
Secondary Outcome Measure Information:
Title
Prevalence and severity of sleep disorders
Description
To assess the effects of dialysis on sleep parameters and determine the prevalence and severity of sleep disorders.
Time Frame
06 months
Title
Change in pulmonary function.
Description
Lung function tests will be performed during the day, with the patient seated in a comfortable position. For such, the KoKo PFT Spirometer System version 4.11 (nSpire Health, Inc, Louisville, CO, USA) will be used in accordance with the guidelines for the execution of lung function tests established by the Brazilian Society of Pneumology and European Respiratory Society.
Time Frame
06 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: male or female patients aged 18 to 80 years; chronic kidney failure; candidate for kidney transplant with indication for dialysis; cognitive level sufficient for understanding the procedures and following the instructions; absence of dementia or treatment-refractory psychiatric diseases leading to an inability to provide informed consent. and agreement to participate by signing a statement of informed consent. Exclusion Criteria: craniofacial abnormalities; undergoing active treatment of sleep apnea; active malignancy; active alcohol and/or drug abuse;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis VF Oliveira, PhD
Phone
+55 62 999052309
Email
oliveira.lvf@pq.cnpq.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis VF Oliveira, PhD
Organizational Affiliation
Centro Universitário de Anápolis - UniEVANGÉLICA
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Universitário de Anápolis - UniEVANGÉLICA
City
Anápolis
State/Province
GO
ZIP/Postal Code
75083-515
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis VF Oliveira, PhD
Phone
+55 62 33106600
Ext
6717
Email
oliveira.lvf@gmail.com

12. IPD Sharing Statement

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

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