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NCT01234571 Clinical Trial

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

Pulmonary Hypertension Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01234571
Other study ID # 0273-10CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 3, 2010
Last updated November 3, 2010
Start date November 2010

Study information
Verified date October 2010
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority ISRAEL: MINISTER OF HEALTH
Study type Observational

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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 5
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus
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