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Impact of Hemo-dialysis Therapy on Blood Levels of Treprostenil in End Stage Renal Disease Patients With Pulmonary Hypertension

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234571
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  Purpose
Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for administration in the intravenous route. It is approved for treatment of class I - pulmonary hypertension functional capacity stage III-IV. A key factor for the success of pulmonary hypertension therapy is maintaining near constant blood level of a given medications along the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt increase in the pulmonary artery pressure which might lead to acute right ventricular failure and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy due to end-stage renal disease there is a need to document the variation of the blood level along the dialysis cycle.

Condition
Pulmonary Hypertension End-Stage Renal Disease Hemo-dialysis Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 5
Study Start Date: November 2010
Detailed Description:

After giving informed consent 10 ml of blood will be drawn from the study population at the following occasions.

  • Baseline measurement immediately before starting HD therapy.
  • During the hemo-dialysis therapy - every one hour.
  • After the end of the hemo-dialysis therapy - every one hour (a total of four measurements) to record recovery of Treprostenil blood levels.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study.
Criteria

Inclusion Criteria:patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study.

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Mordechai Yigla, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01234571     History of Changes
Other Study ID Numbers: 0273-10CTIL
First Submitted: November 3, 2010
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
Last Verified: October 2010

Keywords provided by Rambam Health Care Campus:
Pulmonary hypertension
Remodulin (Treprostenil sodium)
End-stage renal disease
Hemo-dialysis

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Hypertension, Pulmonary
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases
Renal Insufficiency, Chronic
Renal Insufficiency