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

Primary Purpose

Sepsis, Hypovolemia, Peritonitis

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Focused assessed echocardiography
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, echocardiography, urgent, abdominal surgery

Eligibility Criteria

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

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.

Sites / Locations

  • Lithuanian university of health sciencies

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-echo group

Focussed echocardiography group

Arm Description

Patients get the standard monitoring and treatment based on Good medical practice. Extended monitoring by focused echocardiography is not applied for this group.

The extended cardiac monitoring by focused assessed transthoracic echocardiography is applied.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups.
Comparison of fluid management in both arms (from hospitalisation to the surgery, during the surgery, after the surgery 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.
Comparison of septic shock incidence in both arms.
To compare the manifestation of septic shock (hemodynamics instability not responding to fluid administration, which requires norepinephrine infusion to maintain MAP ≥ 65 mmHg);
Number of ICU-Free days.
To compare ICU free days in both groups.

Full Information

First Posted
July 25, 2016
Last Updated
November 19, 2018
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02846948
Brief Title
The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
Acronym
ECHOCARD
Official Title
The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Hypovolemia, Peritonitis
Keywords
sepsis, echocardiography, urgent, abdominal surgery

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Non-echo group
Arm Type
No Intervention
Arm Description
Patients get the standard monitoring and treatment based on Good medical practice. Extended monitoring by focused echocardiography is not applied for this group.
Arm Title
Focussed echocardiography group
Arm Type
Experimental
Arm Description
The extended cardiac monitoring by focused assessed transthoracic echocardiography is applied.
Intervention Type
Other
Intervention Name(s)
Focused assessed echocardiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inpatient mortality in both treatment arms.
Description
Comparison of 30 days intra-hospital mortality in both arms.
Time Frame
30 days intra-hospital mortality
Secondary Outcome Measure Information:
Title
Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
Description
To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups.
Time Frame
1-5 minutes after anaesthesia induction.
Title
Comparison of fluid management in both arms (from hospitalisation to the surgery, during the surgery, after the surgery up to 24 hours).
Description
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.
Time Frame
up to 24 hours
Title
Comparison of septic shock incidence in both arms.
Description
To compare the manifestation of septic shock (hemodynamics instability not responding to fluid administration, which requires norepinephrine infusion to maintain MAP ≥ 65 mmHg);
Time Frame
up to 30 days
Title
Number of ICU-Free days.
Description
To compare ICU free days in both groups.
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrius Macas, profesor
Organizational Affiliation
Lithuanian university of health sciencies
Official's Role
Study Chair
Facility Information:
Facility Name
Lithuanian university of health sciencies
City
Kaunas
State/Province
A. Mickeviciaus Street 9
ZIP/Postal Code
LT-44307
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

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

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