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Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease

Using CPAP to Prevent Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01859260
Enrollment
0
Registered
2013-05-21
Start date
2013-05-30
Completion date
2014-07-31
Last updated
2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Obstructive Sleep Apnea

Keywords

chronic kidney disease, acute kidney injury, obstructive sleep apnea

Brief 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. 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.

Interventions

DEVICECPAP/autopap

Sponsors

University of South Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. CKD defined by National Kidney Foundation Staging system: eGFR \< 60 2. Overnight sleep study consistent with OSA

Exclusion criteria

1. Currently treated with positive airway pressure for sleep-disordered breathing 2. Hemodynamically unstable, defined as SBP \< 90, or use of vasopressors 3. Intubated or mechanically ventilated 4. Respiratory insufficiency, defined as P/F ratio \< 250, or requiring mechanical ventilation 5. End stage renal disease on renal replacement therapy 6. Contraindication to CPAP, including active emesis, recent intracranial surgery, altered level of consciousness

Design outcomes

Primary

MeasureTime frameDescription
Incidence of acute kidney injuryparticipants will be followed for the duration of hospital stay, an expected average of 5 daysincidence of acute kidney injury during hospitalization (defined as an increase in creatinine by 0.5 mg/dl or more)

Secondary

MeasureTime frameDescription
Nocturnal hypoxiaparticipants will be followed for the duration of hospital stay, an expected average of 5 daysNocturnal hypoxia, defined as oxygen saturation \< 88%
Blood pressure controlparticipants will be followed for the duration of hospital stay, an expected average of 5 daysBlood pressure control, defined as incidence of SBP \> 160
Hospital length of stayparticipants will be followed for the duration of hospital stay, an expected average of 5 daysHospital length of stay
composite outcomeparticipants will be followed for the duration of hospital stay, an expected average of 5 daysComposite 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026