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

NCT ID: NCT02846948

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-02-01

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.

Conditions

Sepsis; Hypovolemia; Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Focussed echocardiography group

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

Group Type: EXPERIMENTAL

Focused assessed echocardiography

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Asta Maculiene

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrius Macas, profesor

Role: STUDY_CHAIR

Lithuanian university of health sciencies

Locations

Lithuanian university of health sciencies

Kaunas, A. Mickeviciaus Street 9, Lithuania

Countries

Lithuania

Other Identifiers

MIP051/2015

Identifier Type: -

Identifier Source: org_study_id