Renal Insufficiency, ChronicNCT02390193
Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
A study testing Hemodialysis in people with Renal Insufficiency, Chronic, run by Centro Universitário de Anapolis at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2015to 3 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- craniofacial abnormalities;
- undergoing active treatment of sleep apnea;
- active malignancy;
- active alcohol and/or drug abuse;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro Universitário de Anápolis - UniEVANGÉLICA
Anápolis, Goiás, 75083-515
Luis VF Oliveira, PhD, +55 62 33106600 ext. 6717, oliveira.lvf@gmail.com
About this study
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
- Being tested
- Hemodialysis
- Keywords
- Chronic kidney disease, Dialysis, Sleep, Pulmonary function, Polysomnography, Upper airway
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis | Experimental | Chronic kidney disease patients undergoing hemodialysis will be recruited consecutively and screened for eligibility using a standardised protocol. Receives: Procedure: Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collapsibility of the upper airway.
Degree of upper airway collapsibility through the negative expiratory pressure test in patients with chronic kidney disease on hemodialysis.
Measured: 06 months
Secondary outcomes (2)
Prevalence and severity of sleep disorders
To assess the effects of dialysis on sleep parameters and determine the prevalence and severity of sleep disorders.
Measured: 06 months
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.
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start2 Jan 2015
- Primary completion2 May 2018
- Study completion3 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário de Anapolis
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Responsible party
- Principal investigator, Luis Vicente Franco de Oliveira, Centro Universitário de Anapolis
- Investigators
- Luis VF Oliveira, PhD, Study chair, Centro Universitário de Anápolis - UniEVANGÉLICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390193
- Sponsor's protocol ID
- 368856/2010
- Status last verified
- Jun 2018
- First submitted
- 11 Mar 2015
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02390193
- Acronym / sponsor ID
- 368856/2010
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease, Dialysis, Sleep, Pulmonary function, Polysomnography, Upper airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centro Universitário de AnapolisUniversity, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Study start
- 2 Jan 2015
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 3 Dec 2020 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | Experimental | Procedure: HemodialysisChronic kidney disease patients undergoing hemodialysis will be recruited consecutively and screened for eligibility using a standardised protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- craniofacial abnormalities;
- undergoing active treatment of sleep apnea;
- active malignancy;
- active alcohol and/or drug abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemodialysisDaytime 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. | Procedure or surgery | Hemodialysis |
Primary outcome
Collapsibility of the upper airway.
Time frame: 06 months
Degree of upper airway collapsibility through the negative expiratory pressure test in patients with chronic kidney disease on hemodialysis.
2 secondary outcomes
Prevalence and severity of sleep disorders
Time frame: 06 months
Change in pulmonary function.
Time frame: 06 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis VF Oliveira, PhD study chair
Centro Universitário de Anápolis - UniEVANGÉLICA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis in people with Renal Insufficiency, Chronic, run by Centro Universitário de Anapolis at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis VF Oliveira, PhD (+55 62 999052309, oliveira.lvf@pq.cnpq.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collapsibility of the upper airway. (time frame: 06 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.