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

NCT02846948 | Completed

• 1 other identifier: MIP051/2015
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Hypovolemia; Peritonitis

Keywords

sepsis; echocardiography; urgent; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Inpatient mortality in both treatment arms.

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

  30 days intra-hospital mortality

Secondary Outcomes (4)

• Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.

  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).

  up to 24 hours

• Comparison of septic shock incidence in both arms.

  up to 30 days

• Number of ICU-Free days.

  up to 30 days

Study Arms (2)

Non-echo group

NO INTERVENTION

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

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

Other: Focused assessed echocardiography

Interventions

Focused assessed echocardiography 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.

Focussed echocardiography group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian university of health sciencies

Kaunas, A. Mickeviciaus Street 9, LT-44307, Lithuania

Location

MeSH Terms

Conditions

Sepsis; Hypovolemia; Peritonitis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Andrius Macas, profesor

  Lithuanian university of health sciencies

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 27, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)