E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
refractory ascites, spontaneous bacterial peritonitis, hepatorenal syndrome |
Therapierefraktärer Aszites, spontan-bakterielle Peritonitis, hepatorenales Syndrom |
|
E.1.1.1 | Medical condition in easily understood language |
ascites, bacterial infection of ascites, renal failure in cirrhosis |
Bauchwassersucht, Infektion von Bauchwasser, Nierenversagen bei Leberzirrhose |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 |
The aim of this study is to investigate the effect of albumin infusion on oxidative albumin modification, on plasma thiol status and on albumin binding capacity for DS in patients who routinely receive albumin infusion for various indications and to relate these findings with neurohumoral parameters. We expect that albumin improves oxidation state of circulating albumin as well as albumin function estimated by DS binding capacity.
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Ziel dieser Studie ist es, den Effekt einer (routinemäßigen) Albumin-Infusion auf den Oxidationsstatus und die DS-Bindungskapazität von Albumin sowie auf den Plasma- Thiolstatus zu untersuchen. Wir erwarten dass durch die Albumininfusion sowohl Oxidationsstatus als auch Bindungsfunktion verbessert werden.
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E.2.2 | Secondary objectives of the trial |
not applicable |
nicht zutreffend |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Routine indication for albumin infusion (hepatorenal syndrome, spontaneous bacterial peritonitis, large-volume paracentesis) - Age >18 years - Informed consent
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- Routineindikation für Albumininfusion bei hepatorenalem Syndrom, spontan-bakterieller Peritonitis oder großvolumiger Parazentese - Alter >18a - Unterschriebene Einverständniserklärung
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E.4 | Principal exclusion criteria |
- Malignant ascites - Presence of hepatocellular carcinoma or advanced extrahepatic neoplasia - Nephrotic syndrome - Albumin infusion >80g within the last 48 hours - Pregnancy |
- Maligner Aszites - HCC oder fortgeschrittenes extrahepatisches Malignom - Nephrotisches Syndrom - Albumininfusion >80g während der letzten 48 Stunden - Schwangerschaft |
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E.5 End points |
E.5.1 | Primary end point(s) |
Albumin binding capacity for dansylsarcosine (DS) |
Albuminbindungskapazität für Dansylsarcosin (DS) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
0h (baseline), 24h, 48h |
0 Std (Ausgangswert), 24 Std, 48 Std |
|
E.5.2 | Secondary end point(s) |
- Redox state of albumin (HMA/HNA1/HNA2) - Plasma thiol status - Neurohumoral parameters (PRC, PCC) |
- Redoxstatus von Albumin (HMA/HNA1/HNA2) - Plasmathiolstatus - Neurohumorale Parameter (PRC, PCC)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0h (baseline), 24h, 48h |
0 Std (Ausgangswert), 24 Std, 48 Std |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 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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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 | |
E.8.9.1 | In the Member State concerned days | |