E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children after open-heart surgery for congenital cardiac disease
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019273 |
E.1.2 | Term | Heart disease congenital |
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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 |
to evaluate whether hypertonic-hyperoncotic solutions infusions in toddlers and children aged up to 5 years after open-heart surgery for congenital cardiac disease improve the cardiac index within 20 hours after application in comparison to placebo (isotonic saline solution)
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E.2.2 | Secondary objectives of the trial |
1) to determine whether the administration of hypertonic-hyperoncotic solutions could influence in comparison to placebo (isotonic saline solution) within the first 20 h after application: • the need of volume replacement • the need of catecholamins • the frequency of a capillary leakage syndrome • the serum level of ANF • the second messenger cyclic Guanosin-3',5´-monophosphat (cGMP) • secondarily effects the cortisol-cortisone converting enzyme 11-ß-HSD • diuresis • the need of diuretics.
2) to investigate wether the administration of hypertonic-hyperoncotic solutions is a safe therapy in this patient collective |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent of the legal guardian and consent of the patient, if applicable • Age: 1 month to 5 years • Patients with up to now untreated cyanotic or acyanotic organic heart defects, after open-heart surgery with cardio-pulmonal-bypass • Body weight: > 3,5 kg up to < 50 kg
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E.4 | Principal exclusion criteria |
• Age > 5 years • Body weight < 3,5 kg or >50 kg • Known hypersensitivity against hydroxyethyl starch in the patient's history • Evidence in the patient's history of hemorrhagic diathesis • Pre-surgical manifest heart insufficiency (NYHA-classification: degree IV) • Thrombopenia (Thr <50000/mm3) at study inclusion • Restricted renal function (creatinin-clearance acc. to Schwartz < 30 ml/min/1,73 m2) • Pre-surgical Na > 150 mmol/l • Pre-surgical hyperchloremia • Calculated serum osmolarity: > 350 mosm/l • Acute life threatening hypovolemic shock • Dehydration • Hyperhydration • Oliguria/Anuria • Known disturbance of haemostasis • Contraindications in the product information (SmPC) of HyperHAES® or Isotonische Kochsalzlösung Fresenius® do apply • participation in another clinical trial with an investigational medicinal product.
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E.5 End points |
E.5.1 | Primary end point(s) |
Cardiac index: at baseline (0 minutes), 15 minutes, 1 hour, 4 hours, 12 hours and 20 hours after application of the study solution (HyperHAES® or Isotonische Kochsalzlösung Fresenius®). The cardiac index will be compared at the different time points to the baseline value, in the time course and between the 2 treatment arms (verums vs. placebo). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 7 |