Investigation of the physical and psychosocial outcomes after living kidney donation - A multicentre cohort study (Safety of Living Kidney Donors)
Organizational Data
- DRKS-ID:
- DRKS00006552
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2014-09-22
- Last update in DRKS:
- 2014-09-22
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The main aim of the study is to examine the physical and psychosocial outcomes of living kidney donors after the transplantation in an interdisciplinary approach (surgery / urology, internal medicine / nephrology, psychosocial medicine). Because in western countries the majority of the donators are of female gender (> 60%) and with increasing number of about 60-year of agethis group will become significant increasing. However, there is a lack of data to their specific risks which will be within the scope of the study for the first time.
Brief summary in scientific language
The study is carried out as a nationwide multicenter study. In a naturalistic design (cohort study) clinical data and self-information of the donor (questionnaires) will be collected before and 8 weeks, 6 and 12 months after the donation. All adult living kidney donors with sufficient German knowledge and place of residence in Germany will be included. Primary aim parameters are the kidney function (GFR) and the quality of life (SF-36) of the donor. Secondary aim parameters are other data about possible physical (e.g., sore healing, blood pressure) and psychosocial (depression, fear, somatization) outcomes after the donation.
Health condition or problem studied
- Free text:
- Risk of living kidney donation
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Quality of life and psychosocial parameters like depression, fear and somatization in living kidney donors will be assessed by means of standardized questionnaires. Furthermore, routine clinical data of the donors and the kidney recipients before and after the surgery (e.g., blood values and urine values, body weight and body height, drug status, sore healing, blood pressure) will be collected.
Endpoints
- Primary outcome:
- Quality of life (SF-36) and kidney function (e-GFR) of the donors in the course of 12 months
- Secondary outcome:
- Physical (e.g., high blood pressure) and psychosocial (e.g., depression, fear) outcomes after living kidney donation.
Study Design
- Purpose:
- Health care system
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Münster
- University medical center Düsseldorf
- University medical center Hamburg
- University medical center Frankfurt a.M.
- University medical center Essen
- University medical center Aachen
- University medical center Mannheim
- Medical center Kaiserslautern
- University medical center Gießen
- University medical center Kiel
- University medical center Heidelberg
- University medical center Mainz
- Medical center Berlin Charité Campus Virchow
- Medical center Berlin Charité Campus Mitte
- University medical center Köln
- University medical center Hannover
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2014-05-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 320
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1. Living kidney donor before nephrectomy 2. written consent
Exclusion Criteria
1. Not German residency 2. A lack of reading comprehensionof German, Turkish or Russian language.
Addresses
Primary Sponsor
- Address:
- WWU MünsterProf. Ursula NellesSchlossplatz 248149 MünsterGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-muenster.de/Rektorat/index.shtml
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Uniklinik MünsterProf. Markus BurgmerDomagkstr. 2248149 MünsterGermany
- Telephone:
- +49(0)251 8352902
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenster.de/index.php?id=psychosomatik
Contact for Public Queries
- Address:
- Uniklinik MünsterDr. phil. Viktoriya WörmannDomagkstr. 2248149 MünsterGermany
- Telephone:
- +49(0)251 8358250
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenster.de/index.php?id=psychosomatik
Principal Investigator
- Address:
- Uniklinik MünsterProf. Markus BurgmerDomagkstr. 2248149 MünsterGermany
- Telephone:
- +49(0)251 8352902
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenster.de/index.php?id=psychosomatik
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität MünsterGartenstraße 210-21448147 MünsterGermany
- Telephone:
- +49-251-9292460
- Fax:
- +49-251-9292478
- 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:
- 2013-10-22
- Ethics committee number:
- 2013-587-f-S
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-12-06
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- 01GY1321 - Förderkennzeichen BMBF
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