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

Not Applicable

Completed

• Conditions: Perioperative/Postoperative Complications; Myocardial Injury
• Interventions: Other: Mean arterial pressure based management; Other: Cardiac index based management

• Registration Number: NCT05391087
• Lead Sponsor: Istanbul Saglik Bilimleri University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Study Start: 2022-06-01
• Primary Completion: 2023-03-28
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion criteria during the protocol:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mean Arterial Pressure (MAP) Group	Mean arterial pressure based management	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
Cardiac Index (CI) Group	Cardiac index based management	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)

Primary Outcome Measures

Name	Time	Method
Postoperative high sensitive troponin change	three days	difference between the mean high sensitive troponin elevation between the groups will be evaluated. high sensitive troponin T will be measured one day before the surgery, and daily after the surgery for three days

Secondary Outcome Measures

Name	Time	Method
90-days mortality	90 days	comparison of mortality frequency on the 90th day of the surgery
postoperative myocardial injury incidence	three days	high-sensitivity troponin T elevation by at least 5 ng/L from the preoperative concentration to at least 20 ng/L

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey