- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02846948
The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients (ECHOCARD)
The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Often sepsis remains undiagnosed at the very beginning because of the concentration to the surgical pathology in perioperative period. This results in unacceptably high mortality. The investigators hypothesize that extended hemodynamic monitoring by focused transthoracic echocardiography will personalize early fluid resuscitation which will improve patient's outcome.
The goals of the investigators study are:
- To conduct two-group randomized controlled clinical trial to compare patient management based on standard monitoring and extended hemodynamic monitoring by focused transthoracic echocardiography in patients undergoing urgent abdominal surgery due to peritonitis.
- To demonstrate that patient management based on extended hemodynamic monitoring by focused echocardiography results in improved survival, reduced incidence of hemodynamic instability during perioperative period.
- To compare an amount of administrated of intravenous fluids in both groups.
The investigators hypothesize that focused echocardiography monitoring will result in more administrated intravenous fluids during perioperative period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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A. Mickeviciaus Street 9
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Kaunas, A. Mickeviciaus Street 9, Lithuania, LT-44307
- Lithuanian university of health sciencies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age more than 18 years old.
- Patients undergoing urgent abdominal surgery due to diffuse peritonitis.
- SOFA score >2.
- Patients who sign an agreement to participate in the study.
Exclusion Criteria:
- Younger than 18 years old.
- Known pregnancy.
- Unconscious patients or those who do not agree to participate in the study.
- Contraindication to central venous or arterial catheterization.
- Patients who were already treated in ICU because of sepsis or septic shock before this surgery.
- Known chronic renal failure.
- Re-laparotomy.
- Peritonitis due to acute mesenteric ischaemia, thrombosis or trauma.
- Dying patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Non-echo group
Patients get the standard monitoring and treatment based on Good medical practice.
Extended monitoring by focused echocardiography is not applied for this group.
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Experimental: Focussed echocardiography group
The extended cardiac monitoring by focused assessed transthoracic echocardiography is applied.
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Focused assessed transthoracic echocardiography is non-invasive, painless procedure.
The transducer is placed on the chest at certain locations and angles to get the required information on patient's condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inpatient mortality in both treatment arms.
Time Frame: 30 days intra-hospital mortality
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Comparison of 30 days intra-hospital mortality in both arms.
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30 days intra-hospital mortality
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
Time Frame: 1-5 minutes after anaesthesia induction.
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To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups.
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1-5 minutes after anaesthesia induction.
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Comparison of fluid management in both arms (from hospitalisation to the surgery, during the surgery, after the surgery up to 24 hours).
Time Frame: up to 24 hours
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Comparison of tow fluids management strategies.
Usual monitoring group - fluid management based on fluid responsiveness based by clinical sings.
FATE group - fluid management based on focused transthoracic echocardiography data.
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up to 24 hours
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Comparison of septic shock incidence in both arms.
Time Frame: up to 30 days
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To compare the manifestation of septic shock (hemodynamics instability not responding to fluid administration, which requires norepinephrine infusion to maintain MAP ≥ 65 mmHg);
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up to 30 days
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Number of ICU-Free days.
Time Frame: up to 30 days
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To compare ICU free days in both groups.
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up to 30 days
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Collaborators and Investigators
Investigators
- Study Chair: Andrius Macas, profesor, Lithuanian university of health sciencies
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIP051/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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