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

Primary Purpose

Myocardial Injury, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mean arterial pressure based management
Cardiac index based management
Sponsored by
Istanbul Saglik Bilimleri University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Injury

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Başakşehir Çam and Sakura City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mean Arterial Pressure (MAP) Group

Cardiac Index (CI) Group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
90-days mortality
comparison of mortality frequency on the 90th day of the surgery

Full Information

First Posted
May 20, 2022
Last Updated
July 3, 2023
Sponsor
Istanbul Saglik Bilimleri University
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1. Study Identification

Unique Protocol Identification Number
NCT05391087
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Saglik Bilimleri University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Injury, Perioperative/Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mean Arterial Pressure (MAP) Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Cardiac Index (CI) Group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Mean arterial pressure based management
Intervention Description
Mean arterial pressure group: Low MAP will be intervened in accordance with the protocol as described in the arm
Intervention Type
Other
Intervention Name(s)
Cardiac index based management
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative high sensitive troponin change
Description
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
Time Frame
three days
Secondary Outcome Measure Information:
Title
postoperative myocardial injury incidence
Description
high-sensitivity troponin T elevation by at least 5 ng/L from the preoperative concentration to at least 20 ng/L
Time Frame
three days
Title
90-days mortality
Description
comparison of mortality frequency on the 90th day of the surgery
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who will undergo pancreatic-hepatic surgery 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: Presence of atrial fibrillation, sepsis, pulmonary embolism Presence of pulmonary embolism, acute coronary syndrome and cerebrovascular accident in the last month Static respiratory system compliance < 35ml/cmH2O Patients with preoperative high sensitive Troponin T value >65ng/liter glomerular filtration rate < 60 ml/min Exclusion criteria during the protocol: Newly developed arrhythmia, embolism, sepsis, Cancellation of planned surgery Postoperative hepatic failure defined as INR>2
Facility Information:
Facility Name
Başakşehir Çam and Sakura City Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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