NCT02390193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

3.3 years

First QC Date

March 11, 2015

Last Update Submit

June 13, 2018

Conditions

Renal Insufficiency, Chronic

Keywords

Chronic kidney diseaseDialysisSleepPulmonary functionPolysomnographyUpper airway

Outcome Measures

Primary Outcomes (1)

  • Collapsibility of the upper airway.

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

    06 months

Secondary Outcomes (2)

  • Prevalence and severity of sleep disorders

    06 months

  • Change in pulmonary function.

    06 months

Study Arms (1)

Hemodialysis

EXPERIMENTAL

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

Procedure: Hemodialysis

Interventions

HemodialysisPROCEDURE

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.

Hemodialysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário de Anápolis - UniEVANGÉLICA

Anápolis, Goiás, 75083-515, Brazil

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • Luis VF Oliveira, PhD

    Centro Universitário de Anápolis - UniEVANGÉLICA

    STUDY CHAIR

Central Study Contacts

Luis VF Oliveira, PhD

CONTACT

+55 62 999052309oliveira.lvf@pq.cnpq.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 17, 2015

Study Start

January 2, 2015

Primary Completion

May 2, 2018

Study Completion

December 3, 2020

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

BR(1)