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

Perioperative/Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391087
• Other study ID #: 2021.12.271
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Istanbul Saglik Bilimleri University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Injury
• Perioperative/Postoperative Complications
• Postoperative Complications
• Wounds and Injuries

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Basaksehir Çam and Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Saglik Bilimleri University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	90-days mortality	comparison of mortality frequency on the 90th day of the surgery	90 days