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

Not Applicable

Withdrawn

• Conditions: Chronic Kidney Disease; Obstructive Sleep Apnea
• Interventions: Device: CPAP/autopap

• Registration Number: NCT01859260
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Study Start: 2013-05-30
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	CPAP/autopap	CPAP/autopap

Primary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury	participants will be followed for the duration of hospital stay, an expected average of 5 days	incidence of acute kidney injury during hospitalization (defined as an increase in creatinine by 0.5 mg/dl or more)

Secondary Outcome Measures

Name	Time	Method
Nocturnal hypoxia	participants will be followed for the duration of hospital stay, an expected average of 5 days	Nocturnal hypoxia, defined as oxygen saturation \< 88%
composite outcome	participants will be followed for the duration of hospital stay, an expected average of 5 days	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
Hospital length of stay	participants will be followed for the duration of hospital stay, an expected average of 5 days	Hospital length of stay
Blood pressure control	participants will be followed for the duration of hospital stay, an expected average of 5 days	Blood pressure control, defined as incidence of SBP \> 160

Trial Locations

Locations (1)

Tampa general hospital; 🇺🇸 Tampa, Florida, United States