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The purpose of this study is to evaluate the effectiveness of using the personal preoperatively assessed cardiac output in high-risk patients to guide perioperative administration of fluids and vasoactive drugs on predefined postoperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment algorithm | Experimental | Patients allocated to the study group will be connected to a cardiac output monitor. An initial haemodynamic assessment will be performed at the beginning of surgery and at regular time intervals (every 15 minutes) during surgery. The personal cardiac output value is targeted. |
|
| Standard of Care | No Intervention | Patients allocated to the control group will receive the standard care of the hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment algorithm targeting individual cardiac output | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of study participants with at least one complication of a composite of 30-day postinterventional complications | composite of 30-day postinterventional complications defined according to the ESA-ESICM guidelines for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine (acute kidney injury stage 1 or higher [KIDGO]; ARDS; anastomotic breakdown [moderate and severe]; arrhythmia [severe]; cardiac arrest; cardiogenic pulmonary oedema [severe]; deep vein thrombosis [moderate and severe]; delirium; GI bleeding [severe]; Infection, source uncertain [severe]; bloodstream infection [severe]; myocardial infarction [severe]; pneumonia [severe]; paralytic ileus [severe]; postoperative haemorrhage [severe]; pulmonary embolism [severe]; stroke [severe]; superficial, deep, organ/space surgical site infection [severe]; urinary tract infection [severe]; death) | up tp 90 days after study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day-mortality | up to 7 days after study enrollment | |
| 30-day-mortality | up to 30 days after study enrollment | |
| 90-day-mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Saugel, MD | Universitätsklinikum Hamburg-Eppendorf | Study Chair |
| Julia Wagner, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40586833 | Derived | Krieg N, Baumbach P, Ceanga IA, Standke A, Graler MH, Claus RA, Nicklas JY, Winkler MS, Saugel B, Coldewey SM. Prognostic value of perioperative changes in serum primary metabolites in patients after major surgery under general anesthesia: an exploratory secondary analysis of the TAPIR trial. Can J Anaesth. 2025 Jun;72(6):954-965. doi: 10.1007/s12630-025-02984-6. Epub 2025 Jun 30. | |
| 32711724 |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| up to 90 days after study enrollment |
| ICU length of stay | up to 90 days after study enrollment |
| hospital length of stay | up to 90 days after study enrollment |
| postoperative morbidity survey on days 3, 7, 14, 30 | up to 90 days after study enrollment |
| postoperative cognitive dysfunction | from day 3 after surgical intervention | up to 90 days after study enrollment |
| Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine | up to 90 days after study enrollment |
| perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators | up to 90 days after study enrollment |
| Derived |
| Nicklas JY, Diener O, Leistenschneider M, Sellhorn C, Schon G, Winkler M, Daum G, Schwedhelm E, Schroder J, Fisch M, Schmalfeldt B, Izbicki JR, Bauer M, Coldewey SM, Reuter DA, Saugel B. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth. 2020 Aug;125(2):122-132. doi: 10.1016/j.bja.2020.04.094. |