E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute kidney injury postoperatively in connection with heart surgery |
Akut njursvikt i samband med hjärtkirurgi |
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E.1.1.1 | Medical condition in easily understood language |
Acute renal failure |
Akut njursvikt |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 investigate the effects of levosimendan vs. placebo on the kidney glomerular filtration rate (GFR). |
Att undersöka effekten av levosimendan vs placebo på njurens glomerulära filtrationen (GFR). Primär end-point är förändring i GFR (ml/min) mätt med infusionsclearance av Cr-EDTA. |
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E.2.2 | Secondary objectives of the trial |
Renal blood flow (RBF), renal vascular resistance (RVR), filtration fraction (GFR / RBF), diuresis, renal sodium excretion, cardiac output (CO), mean arterial pressure (MAP), heart rate, central venous pressure (CVP). |
Renalt blodflöde (RBF), renal vaskulär resistans (RVR), filtrationsfraktion (GFR/RBF), diures, renal natriumutsöndring, cardiac output (CO), medelartärtryck (MAP), hjärtfrekvens och centralt ventryck (CVP). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patient to undergo a planned heart surgery with heart-lung machine -Patient must have normal renal function preoperatively, s-creatinine <110 umol/L -Age > 18 years -Patient must have developed acute renal failure, defined as serum creatinine increase> 50% or 27 mmol / L -Patient and/or family members must be in favor of participating in the investigation |
1. Patienten skall genomgå ett planerat hjärtkirurgiskt ingrepp med hjärtlungmaskin 2. Patienten skall ha normal njurfunktion preoperativt, s-kreatinin < 110 umol/L 3. Patienten skall vara över 18 år 4. Patienten skall ha utvecklat akut njursvikt definierad som s-kreatininstegring > 50% eller 27 mmol/L 5. Patienten och/eller anhöriga skall vara positiva till inklusion
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E.4 | Principal exclusion criteria |
-Ongoing treatment with inotropes such as milrinone, levosimendan, dopamine or dobutamine (norepinephrine does not count as inotropic drugs) -Second central venous saturation <60% despite optimization of volume status and hematocrit -Pregnant women in the first trimester due 51 Cr-EDTA (radiolabeled) -Pregnant women due lack of documentation of levosimendan |
1. Pågående behandling med inotropa läkemedel såsom milrinon, levosimendan, dopamin eller dobutamin. Noradrenalin räknas ej som inotropt läkemedel 2. Centralvenös mättnad <60% trots optimering av volymsstatus och hematokrit 3. Gravida kvinnor i första trimestern p.g.a. 51 Cr-EDTA (radioaktivt märkt) 4. Gravida kvinnor p.g.a. avsaknad av dokumentation av levosimendan
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in GFR (mL/min) measured by infusion clearance of Cr-EDTA. |
Förändring i GFR (ml/min) mätt med infusionsclearance av Cr-EDTA. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
70 minutes after infusion of levosimendan |
70 minuter efter infusion av levosimendan |
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E.5.2 | Secondary end point(s) |
Renal blood flow (RBF), renal vascular resistance (RVR), filtration fraction (GFR / RBF), diuresis, renal sodium excretion, cardiac output (CO), mean arterial pressure (MAP), heart rate, central venous pressure (CVP). |
Renalt blodflöde (RBF), renal vaskulär resistans (RVR), filtrationsfraktion (GFR/RBF), diures, renal natriumutsöndring, cardiac output (CO), medelartärtryck (MAP), hjärtfrekvens och centralt ventryck (CVP). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
70 minutes after infusion of levosimendan |
70 minuter efter infusion av levosimendan |
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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 | No |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.6 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 | No |
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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The study will be terminated after follow-up of last patient is completed |
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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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |