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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00013757 |
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Date of registration:
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29/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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G1-cellcycle Arrest biomarker IGFBP-7 and TIMP-2 as predictors for an Extended postoperative ICU (Intensive Care Unit) stay following vascular surgery at the abdominal aorta
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Scientific title:
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G1-cellcycle Arrest biomarker IGFBP-7 and TIMP-2 as predictors for an Extended postoperative ICU (Intensive Care Unit) stay following vascular surgery at the abdominal aorta - ROCCET-Trial |
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Date of first enrolment:
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05/02/2018 |
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Target sample size:
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100 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00013757 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Thorsten
Brenner |
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Address:
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Im Neuenheimer Feld 110
69120
Heidelberg
Germany |
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Telephone:
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06221-56-39418 |
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Email:
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Thorsten.Brenner@med.uni-heidelberg.de |
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Affiliation:
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Klinik für Anästhesiologie |
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Name:
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Thorsten
Brenner |
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Address:
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Im Neuenheimer Feld 110
69120
Heidelberg
Germany |
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Telephone:
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06221-56-39418 |
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Email:
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Thorsten.Brenner@med.uni-heidelberg.de |
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Affiliation:
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Klinik für Anästhesiologie |
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Key inclusion & exclusion criteria
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Inclusion criteria: aortic surgery (via laparotomy or endovascular)
Exclusion criteria: - not fulfilling the inclusion criteria
- not able to give writen informed consent
- not willing to participate
Age minimum:
18 Years
Age maximum:
108 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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N17.9
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Acute renal failure, unspecified
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N17.9
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Intervention(s)
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Group 1: This trial intends to enable physicans to predict kidney injury due to aortic surgery (via laparotomy or endovascular) at an early stage. This would allow early identificaton of risk patients and thus could help minimize chronic kidney damage, long-term mortality and dialysis dependency.
Therefore blood and urine samples will be collected immediately before and after the surgical procedure, as well as at the first postoperative day. Standardlaboratory and G1-cellcycle Arrest biomarker “insulin like growth factor binding protein-7” (IGFBP-7) and “tissue inhibitor of metalloproteinase-2” (TIMP-2) will be measured.
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Primary Outcome(s)
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For the prediction of a moderate or severe acute kidney injury blood and urine samples will be collected immediately before and after the surgical procedure, as well as at the first postoperative day. Standard laboratory and G1-cellcycle Arrest biomarker “insulin like growth factor binding protein-7” (IGFBP-7) and
“tissue inhibitor of metalloproteinase-2” (TIMP-2) will be measured. IGFBP-7 and TIMP-2 Levels will be measured by a Point of care device in Urine samples. The standard laboratory markers (e.g. creatinine) will be measured in plasma samples at the central lab (University Hospital Heidelberg).
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Secondary Outcome(s)
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Association between IGFBP-7xTIMP-2 urine concentrations and the kidney function immediately after the surgical procedure and at the first postoperative day.
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Source(s) of Monetary Support
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Klinik für Anästhesiologie
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Ethics review
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Status: Approved
Approval date: 04/07/2017
Contact:
ethikkommission-I@med.uni-heidelberg.de
Ethikkommission der Medizinischen Fakultät Heidelberg
+49-6221-338220
ethikkommission-I@med.uni-heidelberg.de
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