Individualized Goal-directed Hemodynamic Therapy Targeting Preoperatively Assessed Personal Cardiac Output Values in Patients Undergoing High-risk Surgical Procedures: a Prospective and Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Complications
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Number of study participants with at least one complication of a composite of 30-day postinterventional complications
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of study participants with at least one complication of a composite of 30-day postinterventional complications
Time Frame: 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 Outcomes
- 7-day-mortality(up to 7 days after study enrollment)
- 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)
- postoperative morbidity survey on days 3, 7, 14, 30(up to 90 days after study enrollment)
- postoperative cognitive dysfunction(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)
- hospital length of stay(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)