Elective high risk surgery according to the definition of the European Society of Anaesthesiology
Conditions
Interventions
Group 1: Patients scheduled for elective high-risk, non-cardiac surgery for any indication.
The HeiPoDD study is a prospective single-center exploratory cohort study.
Surgical procedures and perioper
Sponsors
Ruprecht-Karls-Universität Heidelberg Medizinische Fakultät vertreten durch das Universitätsklinikum Heidelberg und dessen Kaufmännische Direktorin Katrin Erk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: 1. Expected lack of compliance or language barriers 2. ASA classification = 5 3. Jehovah's Witness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No confirmatory trial; multiple complications see secondary endpoints. 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. 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactJan Larmann
Klinik für Anästhesiologie
Outcome results
None listed