E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infectious complications after high-risk cardiothoracic surgery. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051284 |
E.1.2 | Term | Parenteral nutrition |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective of the study is to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on infectious morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after high-risk cardiothoracic surgery. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study are to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on cardiac, cerebral, pulmonary and gastro-intestinal morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after high-risk cardiothoracic surgery. Furthermore, the effect on length of stay in the ICU-, hospital- and on in-hospital mortality will be studied. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with a left ventricular ejection fraction of <35%. • Patients screened by the Mission! Heart Failure Program of the Leiden University Medical Center and scheduled for one of the surgical interventions in this program.
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E.4 | Principal exclusion criteria |
• Less than 18 years old • Emergency operations • Renal impairment as defined by a calculated creatinine clearance of < 25 mL/min using the Cockroft & Gault formula: Crc (men) (ml/min)= [140-age (years)*Total body weight (kg)]/plasma creatinin (µmol/l)*1,23 Crc (women) (ml/min)= [140-age (years)*Total body weight (kg)]/plasma creatinin (µmol/l)*1,05 • Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Infectious complications:
- Systemic Inflammatory Response Syndrome (Two or more of the following: • Temperature >38 ºC or < 36 ºC • Heart rate > 90 bpm • Respiratory rate > 20 breaths/min • White blood cell count > 12.000/mm3, < 4.000/mm3 or 10% of immature cells)
- Sepsis (SIRS plus a documented infection (positive culture) If culture negative suspected infection and one of the following: • Significant edema or positive fluid balance (20mL/kg over 20h) • Hyperglycemia (plasma glucose > 120 mg/dL) in absence of diabetes • Inflammatory variables: plasma C-reactive protein > 2 SD above the normal value. • Mixed venous oxygen saturation (SVO2) > 70 % • Cardiac index > 3.5 L min-1 M-23
Severe sepsis Sepsis associated with organ dysfunction (see appendix F), hypoperfusion abnormalities, or hypotension. Hypoperfusion abnormalities include, but are not limited to: • Arterial hypoxemia (PaO2/fraction of inspired oxigen [FiO2] ratio of <300 torr) • Acute oliguria (urine output < 0.05 mL/kg/h or 45 mL for at least 2 h) • Creatinine > 2.0 mg/dL • Coagulation abnormalities (INR > 1.5 APTT > 60 sec) • Platelet count < 100.000 • Hyperbilirubinemia (plasma total bilirubin > 2mg/dL or 35 mmol/L) • Tissue-perfusion variable: hyperlactatemia (> 2 mmol/L) • Hemodynamic variables: arterial hypotension (systolic blood pressure < 90 mmHg, mean arterial pressure < 70 mmHg, or a systolic blood pressure decrease > 40 mmHg))
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |