Clinical trial NCT01859260: Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
Official title: Using CPAP to Prevent Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Disease
Obstructive Sleep Apnea
Keywords: chronic kidney disease, acute kidney injury, obstructive sleep apnea
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of acute kidney injury
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Nocturnal hypoxia
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Blood pressure control
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Hospital length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: composite outcome
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa general hospital
state: Florida
Study officials:
References:
citation: 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.
citation: Zoccali 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.
citation: Fletcher EC. Obstructive sleep apnea and the kidney. J Am Soc Nephrol. 1993 Nov;4(5):1111-21. doi: 10.1681/ASN.V451111.
citation: Fine 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.
citation: Nicholl 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.