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

Comparison of Arterial Blood Pressure and Cardiac Index-based Hemodynamic Management on Postoperative Myocardial Injury in Patients Undergoing Hepatopancreatic Surgery: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Injury; Perioperative/Postoperative Complications
• Intervention / Treatment: Other: Mean arterial pressure based management; Other: Cardiac index based management

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Başakşehir Çam and Sakura City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Mean arterial pressure based management; Mean arterial pressure group: Low MAP will be intervened in accordance with the protocol as described in the arm
Active Comparator: 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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative high sensitive troponin change	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	three days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istanbul Saglik Bilimleri University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Postoperative Complications
• Other Study ID Numbers: 2021.12.271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No