Heidelberg Perioperative Deep Data Study – a prospective cohort study
Recruiting
- Conditions
- Elective high risk surgery according to the definition of the European Society of Anaesthesiology
- Registration Number
- DRKS00024625
- Lead Sponsor
- Ruprecht-Karls-Universität Heidelberg Medizinische Fakultät vertreten durch das Universitätsklinikum Heidelberg und dessen Kaufmännische Direktorin Katrin Erk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
1. Planned elective high-risk, non-cardiac surgery
for any indication
2. Age = 18 years
3. Ability of subject to understand character and
individual consequences of the clinical study
4. Written informed consent
5. Inclusion into HeiPoDD-Registry after written
informed consent
Exclusion Criteria
1. Expected lack of compliance or language
barriers
2. ASA classification = 5
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o confirmatory trial; multiple complications see secondary endpoints.<br><br>There is no primary endpoint in this study. The objective of this study is to explore postoperative complications using data-driven, personalized risk prediction from a large-scale clinical data-set, supplemented by patient-specific proteome analysis. <br>Adding the data into the HeiPoDD-Registry (DRKS00025924) will facilitate combining the study data with the clinical routine data-set stored in the HeiPoDD-Registry allowing to start a prospective data collection to gather the necessary volume of data to perform more in-depth analyses through machine learning methods.<br>The objective of the research project is the development, validation and publication of algorithms and prediction models as well as the investigation of their predictive performance.<br>
- Secondary Outcome Measures
Name Time Method Typical surgical complications like pain, bleeding, ischemia, thrombosis, embolism, infection, re-operation etc. as well as patient related outcomes (risk factors QoL), cardilogical, respiratory and urological endpoints