Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

NCT02834377 | Completed

• 1 other identifier: TAPIR-1.0
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

Cardiac Output; Hemodynamics; Perioperative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Treatment algorithm

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Patients allocated to the control group will receive the standard care of the hospital.

Interventions

Treatment algorithm targeting individual cardiac output OTHER

Treatment algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Pregnancy
• surgery for palliative treatment
• emergency procedure
• refusal of consent
• participation in another randomized controlled trial

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 32711724 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernd Saugel, MD

  Universitätsklinikum Hamburg-Eppendorf

  STUDY CHAIR

• Julia Wagner, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: July 15, 2016
• Study Start: May 19, 2016
• Primary Completion: June 30, 2017
• Study Completion: October 1, 2017
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)