Clinical trial NCT02846948: The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
Official title: The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Hypovolemia
Peritonitis
Keywords: sepsis
echocardiography
urgent
abdominal surgery
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Inpatient mortality in both treatment arms.
timeFrame: 30 days intra-hospital mortality
Secondary outcomes:
measure: Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
timeFrame: 1-5 minutes after anaesthesia induction.
measure: Comparison of fluid management in both arms (from hospitalisation to the surgery, during the surgery, after the surgery up to 24 hours).
timeFrame: up to 24 hours
measure: Comparison of septic shock incidence in both arms.
timeFrame: up to 30 days
measure: Number of ICU-Free days.
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian university of health sciencies
state: A. Mickeviciaus Street 9
Study officials:
affiliation: Lithuanian university of health sciencies
name: Andrius Macas, profesor
role: STUDY_CHAIR
References: