Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery (TAPIR)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Postoperative Complications

Treatments: Other: Treatment algorithm targeting individual cardiac output

Study type: Interventional

Funder types: Other

Identifiers

NCT02834377

TAPIR-1.0

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

Treatment algorithm

Experimental group

Description:

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.

Treatment:

Other: Treatment algorithm targeting individual cardiac output

Standard of Care

No Intervention group

Description:

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