Status:
UNKNOWN
Bariatric Surgery and Chronic Renal Disease
Lead Sponsor:
McMaster University
Collaborating Sponsors:
American College of Surgeons
McMaster Surgical Associates
Conditions:
Bariatric Surgery
Chronic Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Obesity can be a major driver for the development of chronic kidney disease (CKD), which is a leading cause of death and significant loss in quality of life. A growing body of evidence has shown baria...
Detailed Description
Obesity is a major driver for the development of CKD, which is a leading cause of death and greatly reduces one's quality of life. With a global prevalence of 9.1% (7.2% in Canada), CKD affects an est...
Eligibility Criteria
Inclusion
- Patient age \>18
- Body mass index \> 40 (or \> 35 kg/m2 for patients with comorbidities)
- Diagnosis of CKD stage III (G3a or A2) defined as the presence of any of the following:
- glomerular filtration rate (GFR) under 60 mL/min/1.73 m2 as estimated from serum creatinine or cystatin C with the CKD-EPI equation
- ACR \> 30 mg/g
- Patient is deemed eligible to undergo bariatric surgery according to Ontario Bariatric Network (OBN) guidelines \[contradictions to OBN guidelines include non-Ontario resident, age \>70 years, history of cancer \<2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites \<1 year\]
Exclusion
- Hospital admission for kidney failure or acute kidney injury within 30 days of enrollment
- Documented GFR \> 60 mL/min/1.73 m2 or ACR \< 30 mg/g within 30 days of enrollment
- Documented confounders of kidney function measurement such as urinary tract infection or use of creatinine elevating medications or use of medications which interfere with measurement
- Contradiction to OBN guidelines including non-Ontario resident, age \>70 years, history of cancer \<2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites \<1 year
- Life expectancy \<2 years due to non-CKD causes OR Untreated or inadequately treated psychiatric illness OR Risk of general anesthesia deemed too excessive OR Inability to provide informed consent
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05240443
Start Date
April 1 2022
End Date
June 1 2023
Last Update
February 15 2022
Active Locations (1)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6