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NCT00344916 Clinical Trial

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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00344916
Other study ID # MED.RES.HOS.1996.04.JNB
Secondary ID
Status Completed
Phase Phase 1
First received June 24, 2006
Last updated July 10, 2006

Study information
Verified date June 2006
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Ng-monomethyl-L-arginine (drug)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital Holstebro
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