The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients (ECHOCARD)

November 19, 2018 updated by: Asta Maculiene, Lithuanian University of Health Sciences

The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients

The aim of the study is to identify the diagnostic value of the focused assessed echocardiography in septic patients undergoing urgent abdominal surgery due to peritonitis. The investigators expect that the incidence of hemodynamic instability will be reduced and the survival of the patients will be improved.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
    • A. Mickeviciaus Street 9
      • Kaunas, A. Mickeviciaus Street 9, Lithuania, LT-44307
        • Lithuanian university of health sciencies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Experimental: Focussed echocardiography group
The extended cardiac monitoring by focused assessed transthoracic echocardiography is applied.
Other: Focused assessed echocardiography
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.

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
Comparison of 30 days intra-hospital mortality in both arms.
30 days intra-hospital mortality

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.
To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups.
1-5 minutes after anaesthesia induction.
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
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.
up to 24 hours
Comparison of septic shock incidence in both arms.
Time Frame: up to 30 days
To compare the manifestation of septic shock (hemodynamics instability not responding to fluid administration, which requires norepinephrine infusion to maintain MAP ≥ 65 mmHg);
up to 30 days
Number of ICU-Free days.
Time Frame: up to 30 days
To compare ICU free days in both groups.
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Investigators

  • Study Chair: Andrius Macas, profesor, Lithuanian university of health sciencies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

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)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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