Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)

Study Overview
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Brief Summary
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Cardiovascular morbidity and mortality is high in CKD patients. Nitric oxide (NO) deficiency plays a crucial role in progression of CKD. This leads to endothelial dysfunction, hypertension, and inflammation. Hydrogen sulfide (H2S) could serve as a backup mechanism for NO deficiency in CKD. N-acetylcysteine (NAC) is a derivate of cysteine and this is the main substrate for H2S production. Therefore, NAC should enable us to stimulate H2S production in humans. Our objective is to investigate the effect of NAC on plasma H2S levels and on markers of oxidative stress, inflammation, and endothelial dysfunction in healthy volunteers, CKD patients, and dialysis patients. We hypothesize that there is an increase in H2S levels after treatment with NAC.

Official Title
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Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease

Conditions
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Chronic Kidney Disease, Chronic Kidney Failure, End Stage Kidney Disease, End Stage Renal Disease

Intervention / Treatment
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* Drug: N-acetylcysteine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy volunteers: Adult (> 18 years and older) Healthy, as assessed by medical history, blood pressure, plasma creatinine, and urine dipstick No medication use CKD patient: Adult (> 18 years and older) CKD stage 3-4 (GFR 15-60 ml/min) Hemodialysis patient: Adult (> 18 years and older) Hemodialysis patient Peritoneal dialysis patient: Adult (> 18 years and older) Peritoneal dialysis patient Exclusion criteria: Unable to give informed consent Hypersensitivity to N-acetylcysteine Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br> | Drug: N-acetylcysteine<br>* 4 gifts of N-acetylcysteine 600 mg BID<br>|
| Experimental: CKD patients<br>Patients with CKD stage 3-4 (GFR 15-60 ml/min) | Drug: N-acetylcysteine<br>* 4 gifts of N-acetylcysteine 600 mg BID<br>|
| Experimental: Hemodialysis patients<br> | Drug: N-acetylcysteine<br>* 4 gifts of N-acetylcysteine 600 mg BID<br>|
| Experimental: Peritoneal dialysis patients<br> | Drug: N-acetylcysteine<br>* 4 gifts of N-acetylcysteine 600 mg BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrogen sulfide (H2S) | Investigate the effect of N-acetylcysteine on plasma H2S levels and on markers of oxidative stress, inflammation, and endothelial dysfunction in healthy volunteers, CKD patients, and dialysis patients | After 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Chronic kidney failure, End stage kidney disease, End stage renal disease, Hydrogen sulfide, N-acetylcysteine, Acetylcysteine