Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

• Status: Withdrawn
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meditor Pharmaceuticals Ltd.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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