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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Hypertension End-Stage Renal Disease Hemo-dialysis Therapy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pulmonary hypertension Remodulin (Treprostenil sodium) End-stage renal disease Hemo-dialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* none

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rambam Health Care Campus

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0273-10CTIL

Identifier Type: -

Identifier Source: org_study_id