AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls

NCT ID: NCT03293446

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-07
• Study Completion Date: 2018-11-11

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. Currently, a clinical trial (the BIC-study, MEC-2013-332) is conducted in which patients with CKD and metabolic acidosis receive sodium bicarbonate, sodium chloride, or no treatment (time control) to address the hypothesis that the beneficial effects of acidosis correction are mediated through inhibition of the intrarenal renin-angiotensin system (RAS). It is unknown, however, if and how acute changes in acid-base status affect the intrarenal RAS during CKD. In the present study it is hypothesized that an acute acid load increases the activity of the intrarenal RAS, and that this response is exaggerated in patients with CKD compared with healthy controls.

Conditions

Chronic Kidney Disease stage4

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with chronic kidney disease

Group Type: EXPERIMENTAL

Urinary acidification test

Intervention Type: DIAGNOSTIC_TEST

Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.

Healthy controls

Group Type: ACTIVE_COMPARATOR

Urinary acidification test

Intervention Type: DIAGNOSTIC_TEST

Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.

Interventions

Urinary acidification test

Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ewout Hoorn

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

NL57148.078.16

Identifier Type: -

Identifier Source: org_study_id