Intravenous Fish Oil based Lipid Emulsion to enhance recovery in High-Risk Cardiac Surgery Patients: a phase II multicenter trial

Conditions

critical illness, intensive care unit (ICU), surgery

Brief summary

AFACS, incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery

Detailed description

Time to hospital discharge alive (TDA), Days alive and out of hospital within 30 days, Number of attempts to wean from CPB during surgery, Persistent Organ Dysfunction (POD) + Death within 30 days, Time to ICU discharge alive, ICU and Hospital Readmission rates, Delta Sequential Organ Failure Assessment (SOFA) Score, Duration of mechanical ventilation (invasive and non-invasive), Incidence of stroke, Duration of inotropic/vasopressor/mechanical support, Acute Kidney Injury (by Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3), Number of infections, Overall survival, Physical activity (Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL), Quality of Life (Short Form-36 [SF-36]), Postoperative bleeding, Adverse events (AEs) leading to discontinuation/AEs at least possibly related to the IMP/Serious adverse events (SAEs)

Related papers

No related papers found yet.

Interventions

DRUG0

DRUG9% NaCl

DRUGOmegaven-Fresenius Emulsion zur Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AFACS, incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery	—

Secondary

Measure	Time frame
Time to hospital discharge alive (TDA), Days alive and out of hospital within 30 days, Number of attempts to wean from CPB during surgery, Persistent Organ Dysfunction (POD) + Death within 30 days, Time to ICU discharge alive, ICU and Hospital Readmission rates, Delta Sequential Organ Failure Assessment (SOFA) Score, Duration of mechanical ventilation (invasive and non-invasive), Incidence of stroke, Duration of inotropic/vasopressor/mechanical support, Acute Kidney Injury (by Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3), Number of infections, Overall survival, Physical activity (Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL), Quality of Life (Short Form-36 [SF-36]), Postoperative bleeding, Adverse events (AEs) leading to discontinuation/AEs at least possibly related to the IMP/Serious adverse events (SAEs)	—

Measure

Time frame

Time to hospital discharge alive (TDA), Days alive and out of hospital within 30 days, Number of attempts to wean from CPB during surgery, Persistent Organ Dysfunction (POD) + Death within 30 days, Time to ICU discharge alive, ICU and Hospital Readmission rates, Delta Sequential Organ Failure Assessment (SOFA) Score, Duration of mechanical ventilation (invasive and non-invasive), Incidence of stroke, Duration of inotropic/vasopressor/mechanical support, Acute Kidney Injury (by Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3), Number of infections, Overall survival, Physical activity (Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL), Quality of Life (Short Form-36 [SF-36]), Postoperative bleeding, Adverse events (AEs) leading to discontinuation/AEs at least possibly related to the IMP/Serious adverse events (SAEs)

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Countries

Germany

Outcome results

None listed