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| Name | Class |
|---|---|
| University Hospital, Bonn | OTHER |
| University Hospital Muenster | OTHER |
| University Hospital Goettingen | OTHER |
| Charite University, Berlin, Germany |
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The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy.
A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.
The proposed hypothesis is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately leads to faster time to discharge alive. This in turn significantly improves the patients' mid and long-term outcomes and dramatically reduces associated healthcare related costs.
Duration of intervention: until discharge from ICU, death or postoperative day 7 on ICU, whichever comes first.
Treatment Group: Patients will receive 0.20 g fish oil/kg BW/d (≙ 2 mL Omegaven®/kg BW/d).
Control Group: Patients will receive 0,9% NaCl in dose 2 mL/kg BW/d (placebo).
Follow-up per patient: at day 30, months 3, 6, and 12.
Primary endpoint (Phase II study):
The primary endpoint for this phase II clinical trial is the onset and occurence of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter, and atrial tachycardia, until day 7 after surgery (on ICU and normal ward).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d). |
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| Control group | Placebo Comparator | Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Drug | Omegaven® is a 10% fish oil emulsion with a high percentage of long-chain n-3 fatty acids - mainly eicosapentaenoic acid and docosahexaenoic acid. It optimises the fatty acid pattern in parenteral nutrition and is a source of polyunsaturated n-3 fatty acids as cell membrane components and precursors for eicosanoids. Omegaven® is manufactured by Fresenius-Kabi, Germany and is available in 100 mL bottles for study purpose. Each 100 mL of Omegaven® contains 10 g of fish oil (0.1 g/mL). Timeframe: Day -1: 0.20 g fish oil/kg BW/d (the treatment should be started 24 to 3 h before surgery, can be given as 3-6 hours infusion); intraoperative day 0: no dose; postoperative day 0: 0.20 g fish oil/kg BW/d; postoperative days 1 to max. 7): 0.20 g fish oil/kg BW/d |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation | The primary objective is to demonstrate superiority of fish oil compared to placebo in the prevention of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice. | Postoperative days 0-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical ventilation | Duration of mechanical ventilation | Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up |
| Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Optional tertiary endpoint: Ultrasound measurement of thigh skeletal muscle mass | Ultrasound measurement of thigh skeletal muscle mass | Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery) |
| Optional tertiary endpoint: Functional Status Score for Intensive Care Unit (FSS-ICU) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Stoppe, Prof. Dr. | Contact | 49-931-20130001 | cstoppe@gcp-service.com | |
| Ellen Dresen, Dr. | Contact | +49 931-201 30392 | Dresen_E@ukw.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian Stoppe, Prof. Dr. | Wuerzburg University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Augsburg | Recruiting | Augsburg | Germany |
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| OTHER |
| Wuerzburg University Hospital | OTHER |
| Johannes Gutenberg University Mainz | OTHER |
| University Hospital Augsburg | OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| University Medical Center Rostock | OTHER |
| University Hospital Schleswig-Holstein | OTHER |
| Robert Bosch-Krankenhaus Stuttgart | UNKNOWN |
Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous fish oil-based lipid emulsion (Omegaven®), or placebo.
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Patients as well as clinical staff and outcome assessors not involved in the study will be blinded to study intervention allocation.
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| Intravenous 0.9% Sodium Chloride | Drug | Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention. |
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AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs
| Preoperative day -1 to 12 months follow-up |
| Delta Sequential Organ Failure Assessment Score (SOFA) Score | A scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. | Postoperative days 0-7 |
| Stroke | Incidence of stroke | Postoperative days 0-7 |
| Inotropics/vasopressors | Duration of inotropic/vasopressor support | Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up |
| Acute Kidney Injury | Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3 | Postoperative days 0-7 |
| Infection rate | Number of infections | Postoperative days 0-7 |
| Survival status | Overall survival | ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, months 3, 6, and 12 follow-up |
| Quality of Life (SF-36) | To measure the quality of life | Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up |
| Postoperative bleeding | Bleeding after surgery | Postoperative days 0-7 |
| Time to ICU discharge alive | Number of days alive in the ICU | ICU discharge (approximately 3-4 days after surgery) |
| Time to hospital discharge alive | Number of days alive in the hospital | Hospital discharge (approximately 1-2 weeks after surgery) |
| Physical activity assessment | Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL) | Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up |
| Days alive and out of hospital | Time to be alive and discharge from hospital | Day 30 follow-up, 3, 6, and 12 months follow-up |
| Time to discharge alive | Time to be alive and discharged from ICU/hospital | ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery) |
| Weaning from cardiopulmonary bypass (CPB) | Number of attempts to wean from CPB during surgery | Intraoperative day 0 (during surgery) |
| Persistent Organ Dysfunction + Death | Requiring supportive technologies during the convalescent phase of critical illness | Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up |
| ICU Readmission rates | Readmission to ICU | Day 30 follow-up, 3, 6, and 12 months follow-up |
| Hospital Readmission rates | Readmission to hospital | Day 30 follow-up, 3, 6, and 12 months follow-up |
Functional Status Score for Intensive Care Unit (FSS-ICU) |
| Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery) |
| Optional tertiary endpoint: Short Physical Performance Battery test (SPPB) | Short Physical Performance Battery test (SPPB) | Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery) |
| Optional tertiary endpoint: Hand grip/held dynamometer | Hand grip/held dynamometer | Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery) |
| Optional tertiary endpoint: Inflammatory response | Inflammatory response and immune function (measured by markers of the clinical routine (e.g. interleukin [IL-] -6, IL-1β, IL-2, IL-15, interferon [IFN] -γ, monocyte chemotactic protein [MCP] -1, Ferritin, D-Dimer , IL-10, C-reactive protein [CRP], white blood cell count [WBC], procalcitonin [PCT], tumor necrosis factor-α [TNF-α]). | Intraoperative day 0, postoperative days 0-7 |
| Optional tertiary endpoint: Left ventricular ejection fraction | Left ventricular ejection fractLeft ventricular ejection fractionion | Preoperative day -1, hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, 3 and 6 months follow-up |
| Optional tertiary endpoint: Manual Muscle Testing (MMT) | Manual Muscle Testing (MMT) | Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery) |
| Optional tertiary endpoint: Vasoactive-Inotropic Score (VIS) | Vasoactive-Inotropic Score (VIS) | Postoperative days 0-7 |
| Optional tertiary endpoint: Therapeutic Intervention Scoring System (TISS) | A method for measuring workload and calculating costs in the ICU | Postoperative days 0-7 |
| Optional tertiary endpoint: Development of delirium | Assessed by the CAM ICU score | Postoperative days 0-7 |
| Optional tertiary endpoint: Hemodynamic parameters | Adequate hemodynamic support, as defined by stable Cardiac Index, cardiac output (CO), Cardiac Power Index, mean arterial pressure (MAP), central vein pressure (CVP), pulmonary artery diastolic pressure (to be measured every 8 hours for first 72 hours post-op or until removal of pulmonary artery catheter, whatever comes first | Intraoperative day 0, postoperative days 0-7 |
| Optional tertiary endpoint: Clinical frailty scale | A 9-point scale that quantifies frailty based on function in individual patients | Screening (preoperative day -1 until day -7), day 30 follow-up, 3 months follow-up |
| Optional tertiary endpoint: Simplified Acute Physiology Score (SAPS) | Estimates the probability of mortality for ICU patients on admission | Postoperative days 0-7 |
| Optional tertiary endpoints: Further routine biomarkers | Further routine biomarkers: creatinine, urea, bilirubin, troponin, triglycerides if available | Intraoperative day 0, postoperative days 0-7 |
| Separate Sub-study | Serial blood samples and - if available - tissue samples from patients (if these result from the routine surgical procedure) will be collected in concerning patients at the day before (only blood samples), during surgery (only tissue sample if available), and once daily after surgery while the patients are on ICU (only blood samples):
| Preoperative day -1, intraoperative day 0, postoperative days 0-7, hospital discharge (approximately 1-2 weeks after surgery) |
| Charité Universitätsmedizin Berlin | Recruiting | Berlin | Germany |
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| University of Bonn | Recruiting | Bonn | Germany |
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| University Hospital Goettingen | Recruiting | Göttingen | Germany |
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| University Hospital Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
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| University Medical Center Schleswig-Holstein | Recruiting | Kiel | Germany |
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| University Hospital Mainz | Recruiting | Mainz | Germany |
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| University Hospital Muenster | Recruiting | Münster | Germany |
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| University Medical Center Rostock | Not yet recruiting | Rostock | Germany |
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| Robert Bosch Medical Center | Recruiting | Stuttgart | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| C568345 | fish oil triglycerides |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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