NCT05391087

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Istanbul Saglik Bilimleri University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myocardial Injury
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-03-28
• Completion: 2023-06-30
• First posted: 2022-05-25
• Last updated: 2023-07-05

Locations

1 site across 1 country: Turkey (Türkiye)