Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality

NCT06355362 | Not Yet Recruiting

• 1 other identifier: HeCoMo
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

High-risk Surgery

Keywords

hemodynamic; transfusion; perioperative process quality; intensive care medicine; complications; mortality

Outcome Measures

Primary Outcomes (2)

• Incidence of postoperative complications

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

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

• Incidence of postoperative mortalities

  The incidence of postoperative mortality during the follow-up period

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

Secondary Outcomes (10)

• Implementation rate of preoperative factors impacting postoperative outcome

  During the 48 hours prior to surgery

• Intraoperative hemodynamic characteristics

  Time period during surgery

• Postoperative haemodynamic characteristics

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

• Co-morbidities of patients

  At the day of surgery

• Transfusion of blood components and administration of coagulation factors

  During hospital stay or up to the 30th postoperative day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Patients undergoing elective surgery with increased postoperative morbidity and/or increased postoperative mortality

You may not qualify if:

• Patients undergoing surgery in the field of obstetrics
• Age \< 18 years
• Lack of written informed consent
• Lack of language understanding
• Unwillingness to store disease data on site and share anonymised data as part of the clinical trial

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead

Related Links

• Webpage of the study platform

Study Officials

• Aarne Feldheiser

  Kliniken Essen-Mitte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aarne Feldheiser, MD, PhD

CONTACT

+4920117431001; a.feldheiser@kem-med.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 9, 2024
• Study Start: September 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07