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

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 Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea; Chronic Kidney Disease
• Intervention / Treatment: Device: CPAP/autopap

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Intervention; CPAP/autopap	Device: CPAP/autopap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hospital length of stay	Hospital length of stay	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	participants will be followed for the duration of hospital stay, an expected average of 5 days

Collaborators and Investigators

• Sponsor: University of South Florida

Publications and helpful links

General 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.
• 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.
• Fletcher EC. Obstructive sleep apnea and the kidney. J Am Soc Nephrol. 1993 Nov;4(5):1111-21. doi: 10.1681/ASN.V451111.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: chronic kidney disease, acute kidney injury, obstructive sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Urologic Diseases; Renal Insufficiency; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
• Other Study ID Numbers: TGHCPAPCKD