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

NCT ID: NCT01859260

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-30
• Study Completion Date: 2014-07-31

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.

Conditions

Chronic Kidney Disease; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

CPAP/autopap

Group Type: EXPERIMENTAL

CPAP/autopap

Intervention Type: DEVICE

Interventions

CPAP/autopap

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tampa general hospital

Tampa, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21369754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11729258 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 8305638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18633339 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22222188 (View on PubMed)

Other Identifiers

TGHCPAPCKD

Identifier Type: -

Identifier Source: org_study_id