Suspended

Nitric Oxide's Role in Cirrhosis Management: Impact on Hemodynamics, Renal Function, Vasoactive Systems, and Endotoxemia

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What is being tested

N-monomethyl-L-arginine

Drug
Who is being recruted

Digestive System Diseases+3

+ Liver Diseases

+ Pathologic Processes

From 18 to 70 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Study ContactChiraq Parikh, M.D.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Upon admission, the patients will be physically examined and started on a special diet that will continue throughout the study. During the first four days of the study, the weight, heart rate and blood pressure of the patients will be measured every morning and 24-hour urine will be collected. On day 5, intravenous lines will be inserted in the patient's arms. One line will be used to draw blood samples and the other line will be used to infuse medications. Blood samples will be taken to measure liver and kidney function, nitric oxide, and other hormones that participate in the regulation of body fluids and blood pressure. Inulin and paraaminohippurate infusions (substances used routinely in the study of kidney function) will be started and blood and urine samples will then be taken at periodic intervals. Ninety minutes after the initiation of inulin and PAH infusions, L-NMMA (an investigational drug expected to increase the blood pressure and improve the kidney functions) will be infused. Blood and urine samples will be collected every 30 minutes. These procedures will take 4 hours. A total amount of about 10 tablespoons of blood will be drawn during the study. The patients will be discharged from the GCRC the next morning and restarted on their regular medications.

NCT00005107
Principal SponsorNational Center for Research Resources (NCRR)
Study ContactChiraq Parikh, M.D.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosisLiver Cirrhosis

Criteria

4 inclusion criteria required to participate
Age and sex-matched healthy subjects

Cirrhotic patient with ascites without renal failure

Cirrhotic patients with ascites with functional renal failure

Patients with compensated cirrhosis without previous history of ascites or edema

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

4200 E. Ninth Ave., Box C281

Denver, United StatesOpen 4200 E. Ninth Ave., Box C281 in Google Maps
SuspendedOne Study Center