Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.

Detailed Description
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In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are studied on: renal hemodynamics (GFR and RPF) blood pressure and heart rate lithium clearance plasma levels of vasoactive hormones

Official Title
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NO-Synthesis in Patients With Liver Cirrhosis: Effect of L-NMMA on Renal Hemodynamics, Sodium Excretion and Plasma Levels of Vasoactive Hormones

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: Ng-monomethyl-L-arginine (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy controls Age 20 to 60 years Both men and women Weight below 100 kg Normal clinical examination and laboratory screening Fertile women only if using contraception Informed consent according to the regulations of the local ethics committee Liver cirrhosis Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites P-creatinine < 250 µmol/L Age 20-60 years Both men and women Fertile women only if using contraception Body weight below 100 kg Informed consent according to the regulations of the local ethics committee Exclusion Criteria: Healthy controls History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening Current medication Drugs or alcohol abuse Pregnancy Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances Donation of blood less than 1 month before the experiments Liver cirrhosis Apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease. Drugs or alcohol abuse Pregnancy Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ng-monomethyl-L-arginine (drug)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal hemodynamics, Nitric oxide