Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

Postoperative Complications Clinical Trial

— TAPIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834377
• Other study ID #: TAPIR-1.0
• Status: Completed
• Phase: N/A
• Start date: May 19, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: January 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: October 1, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• Treatment algorithm targeting individual cardiac output

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7-day-mortality		up to 7 days after study enrollment
Secondary	30-day-mortality		up to 30 days after study enrollment
Secondary	90-day-mortality		up to 90 days after study enrollment
Secondary	ICU length of stay		up to 90 days after study enrollment
Secondary	hospital length of stay		up to 90 days after study enrollment
Secondary	postoperative morbidity survey on days 3, 7, 14, 30		up to 90 days after study enrollment
Secondary	postoperative cognitive dysfunction	from day 3 after surgical intervention	up to 90 days after study enrollment
Secondary	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
Secondary	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