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Completed

NCT Number: NCT02834377

Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment algorithm targeting individual cardiac output

Other

Primary outcomes

  1. 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

  1. 7-day-mortality

    Time frame: up to 7 days after study enrollment

  2. 30-day-mortality

    Time frame: up to 30 days after study enrollment

  3. 90-day-mortality

    Time frame: up to 90 days after study enrollment

  4. ICU length of stay

    Time frame: up to 90 days after study enrollment

  5. hospital length of stay

    Time frame: up to 90 days after study enrollment

  6. postoperative morbidity survey on days 3, 7, 14, 30

    Time frame: up to 90 days after study enrollment

  7. postoperative cognitive dysfunction

    Time frame: up to 90 days after study enrollment

    from day 3 after surgical intervention

  8. Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine

    Time frame: up to 90 days after study enrollment

  9. perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators

    Time frame: up to 90 days after study enrollment

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Acronym: TAPIR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2016
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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