Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

Withdrawn before enrolling · Phase 2

Conditions studied: Hypotension, Cardiopulmonary Bypass

In brief

The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.

Key facts

Study ID

NCT00482287

Run by

Meditor Pharmaceuticals Ltd.

People needed

0

Starts

2008-01-01

Expected to finish

2008-06-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women age 18 years or older
• Referred for cardiac surgery requiring the use of CPB.
• Elective or urgent surgeries (non emergency operations).
• LVEF ≥40 based on cardiac catheterization results
• Normal renal function at study entry
• Normal hepatic function (within normal laboratory ranges) at study entry
• Normal coagulation status at study entry as judged by PT, PTT, fibrinogen and platelet count.
• Willingness to participate in the study and adhere to the study design.
• Willingness to sign an informed consent form.

You may not qualify if…

• Emergency operation
• Pulmonary hypertension (PA systolic pressure >60 mmHg)
• Ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8
• Neurological events such as prior CVA, TIA or symptomatic carotid stenosis within 1 year of presenting for surgery
• Body weight <40 Kg
• Pregnancy
• Malignancy within 1 year of presenting for surgery
• Systemic infection as evidenced by elevated WBC or fever >38.5 C
• Usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction.
• Participation in any other investigational drug or device study within 30 days of randomization

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.