Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Other: Treatment algorithm targeting individual cardiac output


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment algorithm<br>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. | Other: Treatment algorithm targeting individual cardiac output<br> <br> |
| No Intervention: Standard of Care<br>Patients allocated to the control group will receive the standard care of the hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Output, Hemodynamics, Perioperative Care