About this trial
Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.
The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.
In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.
In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective surgery with increased postoperative morbidity and/or increased postoperative mortality
Disqualifiers
Patients undergoing surgery in the field of obstetrics
Age < 18 years
Lack of written informed consent
Lack of language understanding
Trial population
The decision as to whether a surgical procedure has an increased risk of postoperative complications and/or postoperative mortality is the responsibility of the study leader at the respective study site. The list of surgical procedures will be agreed between the study site and the head of the study. The presence or absence of co-morbidities is not included in the assessment of perioperative risk.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of postoperative complications
The postoperative complications are graded according to the CLAVIEN-DINDO classification
Incidence of postoperative mortalities
The incidence of postoperative mortality during the follow-up period
Secondary outcomes
Implementation rate of preoperative factors impacting postoperative outcome
Implementation rate in percentage of preoperative factors like fasting periods, preoperative carbohydrate drinks or the use of bowel preparations
Intraoperative hemodynamic characteristics
The longitudinal course and punctual values during surgery of haemodynamic parameters like heart rate and mean arterial pressures and therapies such as infusion volumes and balances, and catecholamine administration
Postoperative haemodynamic characteristics
The longitudinal course and punctual values after surgery up to the third postoperative day of haemodynamic parameters like heart rate and mean arterial pressures and therapies such as infusion volumes and balances, and catecholamine administration
Co-morbidities of patients
Descriptive data about the co-morbidities of the study patients
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: