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

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ClinicalTrials.gov Identifier: NCT01234571
Recruitment Status : Unknown
Verified October 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2010
Last Update Posted : November 4, 2010
Sponsor:
Information provided by:
Rambam Health Care Campus

Brief Summary:
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 or disease
Pulmonary Hypertension End-Stage Renal Disease Hemo-dialysis Therapy

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.

Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : November 2010

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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:


Responsible Party: Dr. Mordechai Yigla, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01234571     History of Changes
Other Study ID Numbers: 0273-10CTIL
First Posted: November 4, 2010    Key Record Dates
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