Myocardial InjuryNCT05391087
Comparison Arterial Blood Pressure and Cardiac Index-based Hemodynamic Management on Postoperative Myocardial Injury
A study testing Mean arterial pressure based management and Cardiac index based management in people with Myocardial Injury and Perioperative/Postoperative Complications, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Myocardial Injury, Perioperative/Postoperative Complications
- What is being tested?
- Mean arterial pressure based management and Cardiac index based management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Newly developed arrhythmia, embolism, sepsis,
- Cancellation of planned surgery
- Postoperative hepatic failure defined as INR>2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul
About this study
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
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.
Read the 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
- Being tested
- Mean arterial pressure based management, Cardiac index based management
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean arterial pressure based managementOther
Mean arterial pressure group: Low MAP will be intervened in accordance with the protocol as described in the arm
Cardiac index based managementOther
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
| Study group | Role | What they receive |
|---|---|---|
| Mean Arterial Pressure (MAP) Group | Active comparator | 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 Receives: Other: Mean arterial pressure based management |
| Cardiac Index (CI) Group | Active comparator | 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) Receives: Other: Cardiac index based management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three days
Secondary outcomes (2)
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
Measured: three days
90-days mortality
comparison of mortality frequency on the 90th day of the surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jun 2022
- Primary completion28 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391087
- Sponsor's protocol ID
- 2021.12.271
- Status last verified
- Jul 2023
- First submitted
- 20 May 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdullah T, Gokduman HC, Eniste IA, Kudas I, Ali A, Kinaci E, Ozden I, Gumus Ozcan F. Mean arterial pressure versus cardiac index for haemodynamic management and myocardial injury after hepatopancreatic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2024 Nov 1;41(11):831-840. doi: 10.1097/EJA.0000000000002059. Epub 2024 Sep 12.
PubMed 39262319
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05391087
- Acronym / sponsor ID
- 2021.12.271
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mean Arterial Pressure (MAP) Group | Active comparator | Other: Mean arterial pressure based managementTarget 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 |
| Cardiac Index (CI) Group | Active comparator | Other: Cardiac index based managementCI: 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) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mean arterial pressure based managementMean arterial pressure group: Low MAP will be intervened in accordance with the protocol as described in the arm | Other | Mean Arterial Pressure (MAP) Group |
| Cardiac index based managementCardiac 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 | Other | Cardiac Index (CI) Group |
Primary outcome
Postoperative high sensitive troponin change
Time frame: three days
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
2 secondary outcomes
postoperative myocardial injury incidence
Time frame: three days
90-days mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Derived from this study: PubMed 39262319Abdullah T, Gokduman HC, Eniste IA, Kudas I, Ali A, Kinaci E, Ozden I, Gumus Ozcan F. Mean arterial pressure versus cardiac index for haemodynamic management and myocardial injury after hepatopancreatic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2024 Nov 1;41(11):831-840. doi: 10.1097/EJA.0000000000002059. Epub 2024 Sep 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mean arterial pressure based management and Cardiac index based management in people with Myocardial Injury and Perioperative/Postoperative Complications, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative high sensitive troponin change (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05391087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.