Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure: A Multicenter, Prospective-randomized Intervention Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Age ≥ 65 years
• Elective non-cardiac surgical operation with intermediate or high operative risk under general anesthesia or combined anesthesia (general and regional anesthesia) as per Figure 1
• ASA (American Society of Anesthesiologists) grade ≥ II
• Qualification for randomization: NT-proBNP ≥ 450pg/ml during routine preoperative evaluation and anesthesia consultation.
Locations
Other Locations
Germany
Justus Liebig University Giessen, University Hospital Giessen and Marburg
RECRUITING
Giessen
Contact Information
Primary
Götz Schmidt, MD
goetz.f.schmidt@chiru.med.uni-giessen.de
+4964198544401
Backup
Marit Habicher, MD
+4964198544401
Time Frame
Start Date:2024-09-01
Estimated Completion Date:2027-03-01
Participants
Target number of participants:1057
Treatments
No_intervention: Standard group
In this group, the anesthesiological risk evaluation is generally conducted in accordance with the current guidelines. Possible additional (instrumental) examinations, intraoperative anesthesiological management, and postoperative inpatient therapy are carried out according to current guidelines and are unaffected by study participation. If services are provided in the control group within the local standards that are also part of the new care model, these will be documented to ensure comparability.
Active_comparator: Intervention group
A cardiology consultation is conducted, which includes a standardized evaluation. This includes, medical history and physical examination:ECG, Echocardiography, Determination of cardiac troponins and natriuretic peptides in the local central laboratory. The echocardiography aims to qualitatively and quantitatively describe the left and right ventricular systolic and diastolic dimensions and function, as well as the valvular apparatus, the collected findings are presented at the interdisciplinary and intersectoral preoperative medical (POM) conference. Bedside visits with the patient are also possible.During this conference, structured preoperative interdisciplinary and intersectoral case discussions take place, involving the attending outpatient physicians. The POM conference consists of Anesthesiology, Cardiologist, Treating surgeon and optimize preoperative therapy and plan further pre-, intra-, and postoperative as well as outpatient care.