An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial on the Effects of EA-230 on the Length of Hospital Stay Following On-Pump Coronary Artery Bypass Grafting Surgery

Conditions

Coronary artery disease

Brief summary

As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria.

Detailed description

As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the ICU and transferred to the general ward, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria., As measured by the median postoperative duration, from the moment of first incision until the time when a patient is actually discharged from the ICU, and discharged from the hospital, respectively, compared between treatment arms., As measured by the median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial compared between treatment arms., As measured by: A. Median cumulative Net Fluid Balance (NFB) at the start of Investigational Medicinal Product (IMP) administration (T0) and up to 24 and 48 hours thereafter, compared between treatment arms. B. Cumulative dose of vasopressors and inotropes used and vasopressor-inotropic scores up to 0, 24 and 48 hours after IMP administration, compared between treatment arms., As determined by: A. Blood plasma levels of EA-230 measured just before the end of infusion (T4) in all patients. B. Blood plasma levels of EA-230 measured at T0, T0.5, T1, T2, T3 and T4 in a subset of patients ., As measured by the Incidence of treatment-emergent (Serious) Adverse Events ((S)AEs) and Adverse Drug Reactions (ADRs) during the trial period.

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGEA-230

DRUGNaCl 29 mg/ml in water for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria.	—

Secondary

Measure	Time frame
As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the ICU and transferred to the general ward, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria., As measured by the median postoperative duration, from the moment of first incision until the time when a patient is actually discharged from the ICU, and discharged from the hospital, respectively, compared between treatment arms., As measured by the median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial compared between treatment arms., As measured by: A. Median cumulative Net Fluid Balance (NFB) at the start of Investigational Medicinal Product (IMP) administration (T0) and up to 24 and 48 hours thereafter, compared between treatment arms. B.	—

Measure

Time frame

As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the ICU and transferred to the general ward, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria., As measured by the median postoperative duration, from the moment of first incision until the time when a patient is actually discharged from the ICU, and discharged from the hospital, respectively, compared between treatment arms., As measured by the median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial compared between treatment arms., As measured by: A. Median cumulative Net Fluid Balance (NFB) at the start of Investigational Medicinal Product (IMP) administration (T0) and up to 24 and 48 hours thereafter, compared between treatment arms. B.

—

Outcome results

None listed