Clinical trial NCT05391087: Comparison Arterial Blood Pressure and Cardiac Index-based Hemodynamic Management on Postoperative Myocardial Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Injury
Perioperative/Postoperative Complications
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative high sensitive troponin change
timeFrame: three days
Secondary outcomes:
measure: postoperative myocardial injury incidence
timeFrame: three days
measure: 90-days mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
Study officials:
References: