Influence of individual hemolysis, haptoglobin- genotype and CD 163 Receptor-activity on acute kidney injury in cardiac surgery patients.
Organizational Data
- DRKS-ID:
- DRKS00005457
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2013-11-26
- Last update in DRKS:
- 2014-09-25
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Hp-AKI
URL of the study
No Entry
Brief summary in lay language
During heart surgery with cardio-pulmonal-Bypass, kidney injury can occur. With this Trial mechanism of kidney injury and protective mechanism will be examined. For this purpose blood probes will be taken during surgery and on the first day after surgery. During five days after surgery acute kidney injury will be classified by standard daily Parameters (Urine Output and blood Parameter). Furthermore, AKI will be evaluated by a set of two biomarkers: TIMP-2 and IGFBP-7.
Brief summary in scientific language
During cardiac surgery with cardio-pulmonal-bypass, acute kidney injury can occur. With this Trial one aspect of kidney injury by hemolyis will be examined. For this purpose blood probes will be taken during surgery and on the first day after surgery. Analyzing concentration of preoperative, intraoperative and postoperative haptoglobin and free hemoglobin, haptoglobin genotype and binding capacities in cardiac surgery patients. During five days after surgery acute kidney injury will be classified by the AKIN cirteria by diuresis and serum creatinine. Furthermore, AKI will be evaluated by a set of two biomarkers: TIMP-2 and IGFBP-7, which will be taken at 4 measure points from patient urine samples.
Health condition or problem studied
- ICD10:
- N17.9 - Acute renal failure, unspecified
- ICD10:
- Z95.1 - Presence of aortocoronary bypass graft
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- During cardiac surgery with cardio-pulmonal-bypass, acute kidney injury can occur. With this Trial one aspect of kidney injury by hemolyis will be examined. For this purpose blood probes will be taken during surgery and on the first day after surgery. During five days after surgery acute kidney injury will be classified by the AKIN (Acute Kidney Injury Network) cirteria by diuresis and serum creatinine. Analyzing concentration of preoperative, intraoperative and postoperative haptoglobin and free hemoglobin, haptoglobin genotype and binding capacities and injury mechanism on cellular base in cardiac surgery patients. Furthermore, AKI will be evaluated by a set of two biomarkers: TIMP-2 and IGFBP-7 (NephroCheck® Test, Astute140® Meter, Astute Medical, Inc., 3550 General Atomics Court MS 02/641, San Diego, CA 92121, USA), which will be taken at 4 measure points from patient urine samples. Grouping of patients for analyis: Group 1 AKIN > 0 Group 2 AKIN = 0
Endpoints
- Primary outcome:
- Bloodprobes for determination of Haptoglobin and free hemoglobin concentration preoperative (after anesthesia induction), intraoperative (Start and End) and postoperative (surgery-day and day 1) Analysis of haptoglobin Genotyp and CD 163 receptor acitivity.
- Secondary outcome:
- Acute kidney injury day one to five according to AKIN Criteria (diureses and Serum creatinine) and evaluation of the concentration of the biomarkers TIMP-2 and IGFBP-7.
Study Design
- Purpose:
- Prevention
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Anästhesiologie Göttingen
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-07-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2014-04-01
- Target Sample Size:
- 150
- Final Sample Size:
- 150
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Aorto-coronare Bypass surgery
Exclusion Criteria
Extracorporale membranoxygenation, kidney failure requiering dialysis aortokoronare Bypass-surgery in combination with impossible consent Information, incomplete datasets
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin GöttingenRobert-Koch-Straße 4037099 GöttingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.humanmedizin-goettingen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin GöttingenDr. Anna WetzRobert-Kochstraße 4037075 GöttingenGermany
- Telephone:
- 00495513922995
- Fax:
- 00495513913886
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zari.de
Contact for Public Queries
- Address:
- Universitätsmedizin GöttingenDr. Anna WetzRobert-Kochstraße 4037075 GöttingenGermany
- Telephone:
- 00495513922995
- Fax:
- 00495513913886
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zari.de
Principal Investigator
- Address:
- Universitätsmedizin GöttingenDr. Anna WetzRobert-Kochstraße 4037075 GöttingenGermany
- Telephone:
- 00495513922995
- Fax:
- 00495513913886
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zari.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin GöttingenRobert-Koch-Straße 4037099 GöttingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.humanmedizin-goettingen.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universitätsmedizin GöttingenVon-Siebold-Straße 337075 GöttingenGermany
- Telephone:
- +49-551-3961261
- Fax:
- +49-551-3969536
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-02-17
- Ethics committee number:
- 17/2/13
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-03-20
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry