Skip to main content
Clinical Trials/NCT02846948
NCT02846948
Completed
Not Applicable

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

Lithuanian University of Health Sciences1 site in 1 country131 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Lithuanian University of Health Sciences
Enrollment
131
Locations
1
Primary Endpoint
Inpatient mortality in both treatment arms.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
February 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asta Maculiene

Principal Investigator

Lithuanian University of Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Age more than 18 years old.
  • Patients undergoing urgent abdominal surgery due to diffuse peritonitis.
  • SOFA score \>
  • 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.

Outcomes

Primary Outcomes

Inpatient mortality in both treatment arms.

Time Frame: 30 days intra-hospital mortality

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

Secondary Outcomes

  • 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)
  • Number of ICU-Free days.(up to 30 days)
  • Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.(1-5 minutes after anaesthesia induction.)
  • Comparison of septic shock incidence in both arms.(up to 30 days)

Study Sites (1)

Loading locations...

Similar Trials