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NCT Number: NCT02846948

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian university of health sciencies

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: 1-5 minutes after anaesthesia induction.

    To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups.

  2. Comparison of fluid management in both arms (from hospitalisation to the surgery, during the surgery, after the surgery up to 24 hours).

    Time frame: 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.

  3. Comparison of septic shock incidence in both arms.

    Time frame: 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);

  4. Number of ICU-Free days.

    Time frame: up to 30 days

    To compare ICU free days in both groups.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Acronym: ECHOCARD

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 27, 2016
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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