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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513526-27-00 | EU Trial (CTIS) Number | ||
| 2016-001788-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Biotest | INDUSTRY |
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The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to
The control group receives Standard-of-Care treatment. The intervention group is additionally treated with IgGAM (Pentaglobin®) as an add-on treatment to Standard-of-Care.
Pentaglobin® is administered by continuous intravenous infusion over a period of 5 days of 0.4 ml/kg body weight/hour until the total dose of 7 ml/kg body weight/day is reached.
Primary outcome: Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis.
The MOF score is determined in the morning. The following score points are distributed per organ: Normal organ function: 0 score points; organ dysfunction: 1 score point; single organ failure: 2 score points. A score > 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score was obtained are assigned a score of 10 score points.
Secondary outcome:
Exploratory objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Standard of Care treatment | |
| Verum arm | Active Comparator | Standard of Care treatment + Pentaglobin® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentaglobin®/Standard of Care | Drug | Standard-of-Care treatment + Pentaglobin® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis. | The MOF score is determined in the morning. The following points are distributed per organ: Normal organ function: 0 points; organ dysfunction: 1 point; single organ failure: 2 points. A score > 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score are assigned a score of 10 points. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Death within 28 days | Evaluation of death within 28-days. | 28 days |
| Death within 90 days | Evaluation of death within 90-days. | 90 days |
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Inclusion Criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Center for Translational & Clinical Research (CTC-A) | Contact | PEPPER@ukaachen.de |
| Name | Affiliation | Role |
|---|---|---|
| Gernot Marx, Univ.-Prof. | RWTH Aachen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin | Recruiting | Vienna | 1090 | Austria |
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The control group receives a Standard-of-Care treatment. The intervention group is additionally treated with IgGAM (Pentaglobin®) as an add-on treatment to Standard-of-Care.
The preparation to be provided contains (per ml solution) 50 mg human plasma proteins, of which ≥ 95 % are immunoglobulins: IgM 6 mg, IgA 6 mg and IgG 38 mg. The IgG subclass distribution is IgG1 ~ 63 %, IgG2 ~ 26 %, IgG3 ~ 4 %, IgG4 ~ 7 %.
Pentaglobin® is administered by continuous intravenous infusion over a period of 5 day of 0.4 ml/kg body weight/hour until the total dose of 7 ml/kg body weight/day is reached.
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| Change in MOF Score from baseline to day 5 | Change in MOF Score from baseline to day 5. | 5 days |
| Multi-Organ Failure (i.e., > 4 MOF points) on day 7 | MOF (i.e., > 4 MOF points) on day 7. | 7 days |
| Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin | Terminated | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitätsklinikum Regensburg, Klinik für Anästhesiologie | Recruiting | Regensburg | Bavaria | 93053 | Germany |
|
| Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
|
| Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin | Recruiting | Berlin | State of Berlin | 12203 | Germany |
|
| Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care | Recruiting | Aachen | 52074 | Germany |
|
| Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie | Recruiting | Bochum | 44892 | Germany |
|
| Klinikum Westfalen, Knappschaftskrankenhaus Dortmund, Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie | Terminated | Dortmund | 44309 | Germany |
| Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie | Withdrawn | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie | Withdrawn | Düsseldorf | 40225 | Germany |
| Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie | Recruiting | Frankfurt | 60590 | Germany |
|
| Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie | Recruiting | Freiburg im Breisgau | 79106 | Germany |
|
| Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin | Recruiting | Hamburg | 20246 | Germany |
|
| Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin | Withdrawn | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg, Anästhesiologische Klinik | Withdrawn | Heidelberg | 69120 | Germany |
| Klinikum Magdeburg, Klinik für Intensivmedizin | Withdrawn | Magdeburg | 39130 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie | Withdrawn | Mainz | 55131 | Germany |
| Klinikum der Universität München, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie | Recruiting | München | 81377 | Germany |
|
| Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin | Recruiting | Nuremberg | 90419 | Germany |
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| Heinrich-Braun-Klinikum gGmbH, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie | Recruiting | Zwickau | 08060 | Germany |
|
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| 30832742 | Derived | Kalvelage C, Zacharowski K, Bauhofer A, Gockel U, Adamzik M, Nierhaus A, Kujath P, Eckmann C, Pletz MW, Bracht H, Simon TP, Winkler M, Kindgen-Milles D, Albertsmeier M, Weigand M, Ellger B, Ragaller M, Ullrich R, Marx G. Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial. Trials. 2019 Mar 4;20(1):156. doi: 10.1186/s13063-019-3244-4. |
| ID | Term |
|---|---|
| D010538 | Peritonitis |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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