NCT05391087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

May 20, 2022

Last Update Submit

July 3, 2023

Conditions

Myocardial InjuryPerioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • postoperative myocardial injury incidence

    three days

  • 90-days mortality

    90 days

Study Arms (2)

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

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)

Other: Cardiac index based management

Interventions

Mean arterial pressure based managementOTHER

Mean arterial pressure group: Low MAP will be intervened in accordance with the protocol as described in the arm

Mean Arterial Pressure (MAP) Group
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

Cardiac Index (CI) Group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 39262319DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

June 1, 2022

Primary Completion

March 28, 2023

Study Completion

June 30, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

TU(1)