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

Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension; End-Stage Renal Disease; Hemo-dialysis Therapy

Phase: N/A

Status: Not yet recruiting

Sponsored by: Rambam Health Care Campus

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 Details

Study design: Observational Model: Case-Only, Time Perspective: Prospective

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- none

Locations and Contacts

Additional Information

Starting date: November 2010
Last updated: November 3, 2010

Page last updated: August 23, 2015

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