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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
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01234571
First received: November 3, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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
Pulmonary Hypertension
End-Stage Renal Disease
Hemo-dialysis Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 5
Study Start Date: November 2010
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Mordechai Yigla, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01234571     History of Changes
Other Study ID Numbers: 0273-10CTIL
Study First Received: November 3, 2010
Last Updated: November 3, 2010
Health Authority: ISRAEL: MINISTER OF HEALTH

Keywords provided by Rambam Health Care Campus:
Pulmonary hypertension
Remodulin (Treprostenil sodium)
End-stage renal disease
Hemo-dialysis

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
 Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 21, 2013