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Clinical Trial 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.


Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01234571
Study type Observational
Source Rambam Health Care Campus
Contact
Status Not yet recruiting
Phase N/A
Start date November 2010

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