Role of Nitric Oxide in Cirrhosis: Relationship With Systemic Hemodynamics, Renal Function, Vasoactive Systems and Endotoxemia
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Contact: | Chiraq Parikh, M.D. |
| Phone: | 1-303-266-0771 |
This study is to determine whether a compound, nitric oxide, made within the body, is the
factor responsible for the changes in blood pressure and renal (kidney) functions that may
occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes
poor liver function) will be eligible to participate. A group of healthy subjects will also
be studied to compare the effects of the treatment to patients with cirrhosis and to confirm
safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be
enrolled in the study.
factor responsible for the changes in blood pressure and renal (kidney) functions that may
occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes
poor liver function) will be eligible to participate. A group of healthy subjects will also
be studied to compare the effects of the treatment to patients with cirrhosis and to confirm
safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be
enrolled in the study.
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.
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.
Inclusion Criteria:
- Patients with compensated cirrhosis without previous history of ascites or edema
- Cirrhotic patient with ascites without renal failure
- Cirrhotic patients with ascites with functional renal failure
- Age and sex-matched healthy subjects
We found this trial at
1
site
Click here to add this to my saved trials
