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 because the information has not been verified recently.
Verified October 2010 by Rambam Health Care Campus.
Recruitment status was Not yet recruiting
Information provided by:
Rambam Health Care Campus
First received: November 3, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
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.
End-Stage Renal Disease
||Observational Model: Case-Only
Time Perspective: Prospective
| Estimated Enrollment:
| Study Start Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
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||Dr. Mordechai Yigla, Rambam Health Care Campus
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 3, 2010
||November 3, 2010
||ISRAEL: MINISTER OF HEALTH
Keywords provided by Rambam Health Care Campus:
Remodulin (Treprostenil sodium)
End-stage renal disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Kidney Failure, Chronic
Respiratory Tract Diseases
Renal Insufficiency, Chronic