A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP

Cardiometabolics80 enrolled

Overview

To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Disease

Interventions

CMI X-11SDRUG

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass: * Either: * Age ≥ 70 to \<80 with a Parsonnet Mortality Risk Score of ≥13 (poor risk); OR * Age ≥ 80

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

ICU Time

Time frame: 30 to 45 days post-surgery

Data from ClinicalTrials.gov

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