Chronic Kidney DiseaseNCT01859260
Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
A study testing CPAP/autopap in people with Chronic Kidney Disease and Obstructive Sleep Apnea, run by University of South Florida at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with chronic kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia due to OSA is associated with worsening kidney function. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease, Obstructive Sleep Apnea
- What is being tested?
- CPAP/autopap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2013to Jul 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD defined by National Kidney Foundation Staging system: eGFR < 60
- Overnight sleep study consistent with OSA
Who cannot join
- Currently treated with positive airway pressure for sleep-disordered breathing
- Hemodynamically unstable, defined as SBP < 90, or use of vasopressors
- Intubated or mechanically ventilated
- Respiratory insufficiency, defined as P/F ratio < 250, or requiring mechanical ventilation
- End stage renal disease on renal replacement therapy
- Contraindication to CPAP, including active emesis, recent intracranial surgery, altered level of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using CPAP to Prevent Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with chronic kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia due to OSA is associated with worsening kidney function. Hospitalized patients are often exposed to multiple nephrotoxins such as antibiotics, contrast agents, and diuretics, which place them at risk for acute worsening of kidney function. This study aims to determine whether immediate diagnosis and treatment of OSA in CKD patients will decrease the incidence of acute kidney injury during hospitalization. The investigators will evaluate the extent to which this effect can be attributed to a decrease in nocturnal hypoxia and improved blood pressure control. Secondary endpoints include hospital length of stay, and a composite outcome comprised of hemodialysis initiation, major cardiovascular events, and mortality.
- Conditions
- Chronic Kidney Disease, Obstructive Sleep Apnea
- Being tested
- CPAP/autopap
- Keywords
- chronic kidney disease, acute kidney injury, obstructive sleep apnea
- Medical subject headings
- Renal Insufficiency, Chronic, Sleep Apnea, Obstructive, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP/autopapDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | CPAP/autopap Receives: Device: CPAP/autopap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury
incidence of acute kidney injury during hospitalization (defined as an increase in creatinine by 0.5 mg/dl or more)
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes (4)
Nocturnal hypoxia
Nocturnal hypoxia, defined as oxygen saturation < 88%
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Blood pressure control
Blood pressure control, defined as incidence of SBP > 160
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Hospital length of stay
Hospital length of stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
composite outcome
Composite outcome of a) Incidence of major cardiovascular event (acute coronary syndrome, major arrhythmia, or exacerbation of CHF), b) Initiation of hemodialysis c)In-hospital mortality
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start30 May 2013
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859260
- Sponsor's protocol ID
- TGHCPAPCKD
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kanbay A, Buyukoglan H, Ozdogan N, Kaya E, Oymak FS, Gulmez I, Demir R, Kokturk O, Covic A. Obstructive sleep apnea syndrome is related to the progression of chronic kidney disease. Int Urol Nephrol. 2012 Apr;44(2):535-9. doi: 10.1007/s11255-011-9927-8. Epub 2011 Mar 3.
PubMed 21369754Zoccali C, Mallamaci F, Tripepi G. Sleep apnea in renal patients. J Am Soc Nephrol. 2001 Dec;12(12):2854-2859. doi: 10.1681/ASN.V12122854. No abstract available.
PubMed 11729258Fletcher EC. Obstructive sleep apnea and the kidney. J Am Soc Nephrol. 1993 Nov;4(5):1111-21. doi: 10.1681/ASN.V451111.
PubMed 8305638Fine LG, Norman JT. Chronic hypoxia as a mechanism of progression of chronic kidney diseases: from hypothesis to novel therapeutics. Kidney Int. 2008 Oct;74(7):867-72. doi: 10.1038/ki.2008.350. Epub 2008 Jul 16.
PubMed 18633339Nicholl DDM, Ahmed SB, Loewen AHS, Hemmelgarn BR, Sola DY, Beecroft JM, Turin TC, Hanly PJ. Declining kidney function increases the prevalence of sleep apnea and nocturnal hypoxia. Chest. 2012 Jun;141(6):1422-1430. doi: 10.1378/chest.11-1809. Epub 2012 Jan 5.
PubMed 22222188
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CPAP to Prevent Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01859260
- Acronym / sponsor ID
- TGHCPAPCKD
- Conditions
- Chronic Kidney Disease, Obstructive Sleep Apnea
- Keywords
- chronic kidney disease, acute kidney injury, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 30 May 2013 (actual)
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 21 May 2013 (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.
Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with chronic kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia due to OSA is associated with worsening kidney function. Hospitalized patients are often exposed to multiple nephrotoxins such as antibiotics, contrast agents, and diuretics, which place them at risk for acute worsening of kidney function. This study aims to determine whether immediate diagnosis and treatment of OSA in CKD patients will decrease the incidence of acute kidney injury during hospitalization. The investigators will evaluate the extent to which this effect can be attributed to a decrease in nocturnal hypoxia and improved blood pressure control. Secondary endpoints include hospital length of stay, and a composite outcome comprised of hemodialysis initiation, major cardiovascular events, and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Device: CPAP/autopapCPAP/autopap |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD defined by National Kidney Foundation Staging system: eGFR < 60
- Overnight sleep study consistent with OSA
Key exclusion criteria (6 listed)
- Currently treated with positive airway pressure for sleep-disordered breathing
- Hemodynamically unstable, defined as SBP < 90, or use of vasopressors
- Intubated or mechanically ventilated
- Respiratory insufficiency, defined as P/F ratio < 250, or requiring mechanical ventilation
- End stage renal disease on renal replacement therapy
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 |
|---|---|---|
| CPAP/autopap | Device | Intervention |
Primary outcome
Incidence of acute kidney injury
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
incidence of acute kidney injury during hospitalization (defined as an increase in creatinine by 0.5 mg/dl or more)
4 secondary outcomes
Nocturnal hypoxia
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Blood pressure control
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Hospital length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
composite outcome
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Background: PubMed 21369754Kanbay A, Buyukoglan H, Ozdogan N, Kaya E, Oymak FS, Gulmez I, Demir R, Kokturk O, Covic A. Obstructive sleep apnea syndrome is related to the progression of chronic kidney disease. Int Urol Nephrol. 2012 Apr;44(2):535-9. doi: 10.1007/s11255-011-9927-8. Epub 2011 Mar 3.
- Background: PubMed 11729258Zoccali C, Mallamaci F, Tripepi G. Sleep apnea in renal patients. J Am Soc Nephrol. 2001 Dec;12(12):2854-2859. doi: 10.1681/ASN.V12122854. No abstract available.
- Background: PubMed 8305638Fletcher EC. Obstructive sleep apnea and the kidney. J Am Soc Nephrol. 1993 Nov;4(5):1111-21. doi: 10.1681/ASN.V451111.
- Background: PubMed 18633339Fine LG, Norman JT. Chronic hypoxia as a mechanism of progression of chronic kidney diseases: from hypothesis to novel therapeutics. Kidney Int. 2008 Oct;74(7):867-72. doi: 10.1038/ki.2008.350. Epub 2008 Jul 16.
- Background: PubMed 22222188Nicholl DDM, Ahmed SB, Loewen AHS, Hemmelgarn BR, Sola DY, Beecroft JM, Turin TC, Hanly PJ. Declining kidney function increases the prevalence of sleep apnea and nocturnal hypoxia. Chest. 2012 Jun;141(6):1422-1430. doi: 10.1378/chest.11-1809. Epub 2012 Jan 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP/autopap in people with Chronic Kidney Disease and Obstructive Sleep Apnea, run by University of South Florida at 1 site in United States.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Apr 2019. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859260, which also lists 5 linked publications.
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 29 Apr 2019.