Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Other: Treatment algorithm targeting individual cardiac output

• Registration Number: NCT02834377
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-19
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-15
• Primary Completion: 2017-06-30
• Study Completion: 2017-10-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment algorithm	Treatment algorithm targeting individual cardiac output	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany