Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease, Obstructive Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP/autopap
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring chronic kidney disease, acute kidney injury, obstructive sleep apnea
Eligibility Criteria
Inclusion Criteria:
- CKD defined by National Kidney Foundation Staging system: eGFR < 60
- Overnight sleep study consistent with OSA
Exclusion Criteria:
- 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
Sites / Locations
- Tampa general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
CPAP/autopap
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Nocturnal hypoxia
Nocturnal hypoxia, defined as oxygen saturation < 88%
Blood pressure control
Blood pressure control, defined as incidence of SBP > 160
Hospital length of stay
Hospital length of stay
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
Full Information
NCT ID
NCT01859260
First Posted
May 15, 2013
Last Updated
April 25, 2019
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT01859260
Brief Title
Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
Official Title
Using CPAP to Prevent Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects enrolled
Study Start Date
May 30, 2013 (Actual)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Obstructive Sleep Apnea
Keywords
chronic kidney disease, acute kidney injury, obstructive sleep apnea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
CPAP/autopap
Intervention Type
Device
Intervention Name(s)
CPAP/autopap
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury
Description
incidence of acute kidney injury during hospitalization (defined as an increase in creatinine by 0.5 mg/dl or more)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Nocturnal hypoxia
Description
Nocturnal hypoxia, defined as oxygen saturation < 88%
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Blood pressure control
Description
Blood pressure control, defined as incidence of SBP > 160
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
composite outcome
Description
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
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CKD defined by National Kidney Foundation Staging system: eGFR < 60
Overnight sleep study consistent with OSA
Exclusion Criteria:
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
Facility Information:
Facility Name
Tampa general hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21369754
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.
Results Reference
background
PubMed Identifier
11729258
Citation
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.
Results Reference
background
PubMed Identifier
8305638
Citation
Fletcher EC. Obstructive sleep apnea and the kidney. J Am Soc Nephrol. 1993 Nov;4(5):1111-21. doi: 10.1681/ASN.V451111.
Results Reference
background
PubMed Identifier
18633339
Citation
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.
Results Reference
background
PubMed Identifier
22222188
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.
Results Reference
background
Learn more about this trial
Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease
We'll reach out to this number within 24 hrs