Status:
COMPLETED
AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
Lead Sponsor:
Erasmus Medical Center
Conditions:
Chronic Kidney Disease stage4
Eligibility:
MALE
18-99 years
Phase:
NA
Brief Summary
In this study the effect of an acute acid load on the intrarenal renin angiotensin-system is evaluated in patients with chronic kidney disease and healthy controls
Detailed Description
Metabolic acidosis is one of the metabolic complications of chronic kidney disease (CKD). Correction of metabolic acidosis in CKD has been shown to prevent further loss of kidney function over time. C...
Eligibility Criteria
Inclusion
- Patients with CKD:
- Male or female adults (≥18 years)
- Chronic kidney disease stage 4 (eGFR: 15-30 ml/min/1.73 m2, calculated using the CKD-EPI equation)
- Healthy controls:
- Healthy male or female adults (≥ 18 years)
- Normal kidney function (eGFR \> 90 ml/min/1.73 m2, calculated using the CKD-EPI equation)
- Exclusion Criteria:
- CKD patients
- Plasma bicarbonate level \< 20.0 mmol/l
- Serum potassium \>5.5 mmol/l
- Sodium bicarbonate use in the month preceding the test
- Heart failure (NYHA III or IV)
- Liver cirrhosis (Child Pugh B or C)
- Blood pressure \>140/90 mmHg despite the use of 3 different anti-hypertensive drugs
- Kidney transplantation
- Use of calcineurin inhibitors (these immunosuppressive drugs affect acid-base balance)
- Known urea cycle disorder
- Alcoholism or drug use
- Pregnancy
- Current use of antibiotics, NSAIDS or alkalizing drugs (sodium-bicarbonate, citric acid, potassium citrate, acetazolamide)
- Inability to adhere to the study protocol (due to language barrier or intellectual disability)
- Healthy controls:
- eGFR \< 90 ml/min/1.73 m2 (calculated using the CKD-EPI equation)
- Plasma bicarbonate \< 20 mmol/l
- History of, or drugs for, diabetes mellitus
- History of chronic diarrheal disease
- Ileostomy/colostomy
- Known urea cycle disorder
- Alcoholism or drug use
- Pregnancy
- Current use of antibiotics, antihypertensive drugs, NSAIDS or alkalizing drugs (sodium-bicarbonate, citric acid, potassium citrate, acetazolamide)
- Inability to adhere to the study protocol (due to language barrier or intellectual disability)
Exclusion
Key Trial Info
Start Date :
October 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03293446
Start Date
October 7 2016
End Date
November 11 2018
Last Update
June 20 2019
Active Locations (1)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015CN