Comparison Arterial Blood Pressure and Cardiac Index-based Hemodynamic Management on Postoperative Myocardial Injury

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-30

Brief Summary

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The primary aim of this study is to compare mean arterial pressure (MAP) and cardiac index (CI) based intraoperative hemodynamic management in terms of postoperative high sensitive troponin elevation.

The hypothesis of the study is that there will be at least 5ng/L difference between the two groups in terms of troponin elevation occurring in the postoperative period. When power analysis was performed with this primary output, it was calculated that while alpha was 0.05 beta 0.2, 42 patients in each group, a total of 84 patients were required.

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Detailed Description

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Fluid therapy will be started as 2-4 ml/kg/h, according to the clinician's decision for the patient. Afterwards, patients will be managed hemodynamically with one of the MAP and CI algorithms.

Targeted fluid therapy will be administered in accordance with the following definitions of normal and algorithms for both groups.

Normal definitions:

MAP: Baseline MAP +/- 20% and MAP\>65mmHg Baseline MAP: MAP average in the ward at rest the day before surgery

CI: Baseline CI +/- 20% and CI \> 2.2 L/m2/min Baseline CI: CI calculated by MostCare monitor before the anesthesia induction starts

Low MAP intervention If PPV\>14, apply 500ml crystalloid If PPV\>9 and any additional finding regarding hypovolemia, apply 500ml crystalloid If PPV\<10, start/titrate noradrenaline infusion

Low CI intervention If PPV\>9, apply mini fluid challenge (MFC). If MFC is positive, apply 500ml crystalloid.

If MFC is negative, evaluate MAP. If MAP is elevated start/titrate remifentanil. If MAP is not elevated start/titrate dopamine/dobutamine in accordance with SVRI

Conditions

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Myocardial Injury Perioperative/Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Mean Arterial Pressure (MAP) Group

Target MAP: Baseline MAP +/- 20% and MAP\>65mmHg Baseline MAP: MAP average in the ward at rest the day before surgery Low MAP intervention If PPV\>14, apply 500ml crystalloid If PPV\>9 and any additional finding regarding hypovolemia, apply 500ml crystalloid If PPV\<10, start/titrate noradrenaline infusion

Group Type ACTIVE_COMPARATOR

Mean arterial pressure based management

Intervention Type OTHER

Mean arterial pressure group: Low MAP will be intervened in accordance with the protocol as described in the arm

Cardiac Index (CI) Group

CI: Baseline CI +/- 20% and CI \> 2.2 L/m2/min Baseline CI: CI calculated by MostCare monitor before the anesthesia induction starts Low CI intervention If PPV\>9, apply mini fluid challenge (MFC). If MFC is positive, apply 500ml crystalloid.

If MFC is negative, evaluate MAP. If MAP is elevated start/titrate remifentanil. If MAP is not elevated start/titrate dopamine/dobutamine in accordance with systemic vascular resistance index (SVRI)

Group Type ACTIVE_COMPARATOR

Cardiac index based management

Intervention Type OTHER

Cardiac index group: Low CI will be intervened in accordance with the protocol as described in the arm. Additionally, if MAP is lower than target MAP along with a normal CI, this will be intervened with noradrenalin infusion/titration

Interventions

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Mean arterial pressure based management

Mean arterial pressure group: Low MAP will be intervened in accordance with the protocol as described in the arm

Intervention Type OTHER

Cardiac index based management

Cardiac index group: Low CI will be intervened in accordance with the protocol as described in the arm. Additionally, if MAP is lower than target MAP along with a normal CI, this will be intervened with noradrenalin infusion/titration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients who will undergo pancreatic-hepatic surgery
2. Patients over 65 years of age or patients over 45 years of age and with at least one of the following comorbidities:

coronary artery disease, Congestive heart failure, moderate to severe heart valve disease, peripheral artery disease Moderate to Severe Pulmonary hypertension, cerebrovascular accident older than 1 month, History of pulmonary embolism more than 1 month old, Diabetes Mellitus, Hypertension

Exclusion Criteria

1. Presence of atrial fibrillation, sepsis, pulmonary embolism
2. Presence of pulmonary embolism, acute coronary syndrome and cerebrovascular accident in the last month
3. Static respiratory system compliance \< 35ml/cmH2O
4. Patients with preoperative high sensitive Troponin T value \>65ng/liter
5. glomerular filtration rate \< 60 ml/min

1. Newly developed arrhythmia, embolism, sepsis,
2. Cancellation of planned surgery
3. Postoperative hepatic failure defined as INR\>2

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No