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

NCT01859260 | Withdrawn

• 1 other identifier: TGHCPAPCKD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

chronic kidney disease, acute kidney injury, obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Nocturnal hypoxia

  participants will be followed for the duration of hospital stay, an expected average of 5 days

• Blood pressure control

  participants will be followed for the duration of hospital stay, an expected average of 5 days

• Hospital length of stay

  participants will be followed for the duration of hospital stay, an expected average of 5 days

• composite outcome

  participants will be followed for the duration of hospital stay, an expected average of 5 days

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

CPAP/autopap

Device: CPAP/autopap

Interventions

CPAP/autopap DEVICE

Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa general hospital

Tampa, Florida, 33606, United States

Location

Related Publications (5)

• 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.

  PMID: 21369754 BACKGROUND

• 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.

  PMID: 11729258 BACKGROUND

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

  PMID: 8305638 BACKGROUND

• 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.

  PMID: 18633339 BACKGROUND

• 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.

  PMID: 22222188 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sleep Apnea, Obstructive; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 21, 2013
• Study Start: May 30, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 29, 2019

Record last verified: 2013-05

Locations

US (1)