Postoperative Complications
Conditions
Keywords
Cardiac Output, Hemodynamics, Perioperative Care
Brief summary
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.
Interventions
OTHERTreatment algorithm targeting individual cardiac output
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years undergoing a major abdominal procedure (including general, urological, gynaecological, and vascular) with an expected duration of surgery ≥ 90 min or presumed blood loss exceeding 1,000 mL (e.g., intrabdominal vascular surgery) and ≥ 1 of the following high-risk criteria: * acute or chronic renal impairment (serum creatinine ≥ 1.3 mg/dL) * predefined risk factors for cardiac or respiratory complications * Immunodeficiency due to a therapy (e.g., immunosuppressants, chemotherapy, radiation, long-term or high-dose steroids) * Immunodeficiency due to specific diseases (e.g., leukaemia, lymphoma, AIDS) * severe liver impairment (biopsy proven liver cirrhosis plus 1 of the following: portal hypertension or history of upper gastrointestinal bleeding due to portal hypertension or previous episodes of hepatic insufficiency/hepatic encephalopathy/hepatic coma * Age ≥ 80 years
Exclusion criteria
* Age \<18 years * Pregnancy * surgery for palliative treatment * emergency procedure * refusal of consent * participation in another randomized controlled trial * failure to meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of study participants with at least one complication of a composite of 30-day postinterventional complications | up tp 90 days after study enrollment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day-mortality | up to 30 days after study enrollment | — |
| 90-day-mortality | 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 | — |
| 7-day-mortality | up to 7 days after study enrollment | — |
| postoperative cognitive dysfunction | up to 90 days after study enrollment | from day 3 after surgical intervention |
| 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 | — |
| postoperative morbidity survey on days 3, 7, 14, 30 | up to 90 days after study enrollment | — |
Countries
Germany
Outcome results
None listed