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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514804-14-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (above 30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 g/L or below | Experimental | Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below |
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| 20 g/L or below | Active Comparator | receive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin administration | Drug | when albumin serum concentration is at 30 g/L or below |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kindey Injury at Day 7 | To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (=30 g/L) for five days diminishes rate of Acute Kindey Injury at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)). | 7 days after liver transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation | Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation | 7 days after liver transplantation |
| hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loïc JACOB | Contact | +33299282555 | loic.jacob@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pauline HOUSSEL-DEBRY, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 08_CHRU de Tours Hôpital Trousseau | Recruiting | Chambray-lès-Tours | 37170 | France |
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| Label | URL |
|---|---|
| European Medicines Agency Registry | View source |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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hospital length of stay |
| 28 days |
| occurrence of calcineurin inhibitor induced neurotoxicity | occurrence of calcineurin inhibitor induced neurotoxicity | 28 days |
| occurence of calcineurin inhibitor withdraw | occurence of calcineurin inhibitor withdraw | 28 days |
| occurrence of postoperative infections | occurrence of postoperative infections | 28 days |
| occurrence of acute graft rejection | occurrence of acute graft rejection | 28 days |
| occurrence of early graft dysfunction | occurrence of early graft dysfunction | 28 days |
| duration of mechanical ventilation | duration of mechanical ventilation | 28 days |
| reintubation rate | reintubation rate | 28 days |
| Intensive Care Unit length of stay | Intensive Care Unit length of stay | 28 days |
| Intensive Care Unit readmission rate | Intensive Care Unit readmission rate | 28 days |
| All cause mortality | All cause mortality | 28 days |
| 03_APHP Hôpital Beaujon | Recruiting | Clichy | 92110 | France |
|
| 04_CHU de Lille Hôpital Huriez | Recruiting | Lille | 59000 | France |
|
| 05_HCL Hôpital de la Croix Rousse | Recruiting | Lyon | 69004 | France |
|
| 06_CHU de Montpellier Hôpital St Eloi | Recruiting | Montpellier | 34295 | France |
|
| 02_CHU de Bordeaux - Hôpital Haut Leveque | Recruiting | Pessac | 33604 | France |
|
| 01_CHU de Rennes Hôpital Pontchaillou | Recruiting | Rennes | 35000 | France |
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| 09_APHP Hôpital Paul Brousse | Recruiting | Villejuif | 94804 | France |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |