Clinical trial NCT02834377: Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: Cardiac Output
Hemodynamics
Perioperative Care
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of study participants with at least one complication of a composite of 30-day postinterventional complications
timeFrame: up tp 90 days after study enrollment
Secondary outcomes:
measure: 7-day-mortality
timeFrame: up to 7 days after study enrollment
measure: 30-day-mortality
timeFrame: up to 30 days after study enrollment
measure: 90-day-mortality
timeFrame: up to 90 days after study enrollment
measure: ICU length of stay
timeFrame: up to 90 days after study enrollment
measure: hospital length of stay
timeFrame: up to 90 days after study enrollment
measure: postoperative morbidity survey on days 3, 7, 14, 30
timeFrame: up to 90 days after study enrollment
measure: postoperative cognitive dysfunction
timeFrame: up to 90 days after study enrollment
measure: Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine
timeFrame: up to 90 days after study enrollment
measure: perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators
timeFrame: up to 90 days after study enrollment
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Bernd Saugel, MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Julia Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.