Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-19

Study Completion Date

2017-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment algorithm

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.

Group Type EXPERIMENTAL

Treatment algorithm targeting individual cardiac output

Intervention Type OTHER

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Treatment algorithm targeting individual cardiac output

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No