Hypovolemia, Peritonitis, Sepsis
Conditions
Keywords
sepsis, echocardiography, urgent, abdominal surgery
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.
Interventions
OTHERFocused 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.
Sponsors
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient mortality in both treatment arms. | 30 days intra-hospital mortality | Comparison of 30 days intra-hospital mortality in both arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of septic shock incidence in both arms. | up to 30 days | To compare the manifestation of septic shock (hemodynamics instability not responding to fluid administration, which requires norepinephrine infusion to maintain MAP ≥ 65 mmHg); |
| Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms. | 1-5 minutes after anaesthesia induction. | To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups. |
| 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 tow fluids management strategies. Usual monitoring group - fluid management based on fluid responsiveness based by clinical sings. FATE group - fluid management based on focused transthoracic echocardiography data. |
| Number of ICU-Free days. | up to 30 days | To compare ICU free days in both groups. |
Countries
Lithuania
Outcome results
None listed