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

Sepsis Clinical Trial

— ECHOCARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846948
• Other study ID #: MIP051/2015
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: November 2018
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypovolemia
• Peritonitis
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Lithuania	Lithuanian university of health sciencies	Kaunas	A. Mickeviciaus Street 9

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inpatient mortality in both treatment arms.	Comparison of 30 days intra-hospital mortality in both arms.	30 days intra-hospital mortality
Secondary	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.	1-5 minutes after anaesthesia induction.
Secondary	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.	up to 24 hours
Secondary	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);	up to 30 days
Secondary	Number of ICU-Free days.	To compare ICU free days in both groups.	up to 30 days