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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01859260
• Other study ID #: TGHCPAPCKD
• Status: Withdrawn
• Phase: N/A
• Start date: May 30, 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2013
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease
• Kidney Diseases
• Obstructive Sleep Apnea
• Renal Insufficiency, Chronic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP/autopap

Locations

Country	Name	City	State
United States	Tampa general hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

Fletcher EC. Obstructive sleep apnea and the kidney. J Am Soc Nephrol. 1993 Nov;4(5):1111-21. — View 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. — View 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. — View Citation

Zoccali C, Mallamaci F, Tripepi G. Sleep apnea in renal patients. J Am Soc Nephrol. 2001 Dec;12(12):2854-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Nocturnal hypoxia	Nocturnal hypoxia, defined as oxygen saturation < 88%	participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Blood pressure control	Blood pressure control, defined as incidence of SBP > 160	participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Hospital length of stay	Hospital length of stay	participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	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	participants will be followed for the duration of hospital stay, an expected average of 5 days