Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKliniken Essen-Mitte

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Incidence of postoperative complications

The postoperative complications are graded according to the CLAVIEN-DINDO classification

Time frame
From the time of surgery up to hospital discharge or up to the 30th postoperative day
2

Incidence of postoperative mortalities

The incidence of postoperative mortality during the follow-up period

Time frame
From the time of surgery up to one year after surgery, during hospital stay, at three, six, or twelve months after surgery

Secondary outcomes

1

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

Time frame
During the 48 hours prior to surgery
2

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

Time frame
Time period during surgery
3

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

Time frame
Time period from the end of surgery up to the third postoperative day
4

Co-morbidities of patients

Descriptive data about the co-morbidities of the study patients

Time frame
At the day of surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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