Study Stopped
Site did not recruit any patients
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients
A Phase II, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study to Assess the Pharmacokinetics and Pharmacodynamics of MTR105 in Cardiac Surgery Induced Hypotension Patients During Weaning Off Cardiopulmonary Bypass
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2007
CompletedFirst Posted
Study publicly available on registry
June 5, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedApril 7, 2015
April 1, 2015
5 months
June 1, 2007
April 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Hemodynamic parameters
24 hours
Secondary Outcomes (1)
Pharmacokinetics
10 hours
Study Arms (4)
1
OTHERDose level 0.3 mg/kg with 6 active and 2 placebo
2
OTHERDose level 0.6 mg/kg 6 patients active and 2 placebo
3
OTHERDose level 1.2 mg/kg 6 active and 2 placebo
4
OTHERDose level 2.4 mg/kg 6 active and 2 placebo
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny Sappington, MD
University of Pittsburgh Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2007
First Posted
June 5, 2007
Study Start
January 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
April 7, 2015
Record last verified: 2015-04