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

Lithuanian University of Health Sciences

Status: Completed

Conditions: Hypovolemia; Peritonitis; Sepsis

Treatments: Other: Focused assessed echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02846948

MIP051/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

131 participants in 2 patient groups

Non-echo group

No Intervention group

Description:

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

Focussed echocardiography group

Experimental group

Description:

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

Treatment:

Other: Focused assessed echocardiography