SepsisECHOCARDNCT02846948
The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
A study testing Focused assessed echocardiography in people with Sepsis and Hypovolemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hypovolemia, Peritonitis
- What is being tested?
- Focused assessed echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteLithuania
- Study dates
- Jan 2016to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Re-laparotomy.
- Peritonitis due to acute mesenteric ischaemia, thrombosis or trauma.
- Dying patients.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian university of health sciencies
Kaunas, A. Mickeviciaus Street 9, LT-44307
About this study
Official title: The Impact of Extended Hemodynamic Monitoring by 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.
Read the 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.
- Conditions
- Sepsis, Hypovolemia, Peritonitis
- Being tested
- Focused assessed echocardiography
- Keywords
- sepsis, echocardiography, urgent, abdominal surgery
- Medical subject headings
- Sepsis, Hypovolemia, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused assessed echocardiographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Focused assessed echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient mortality in both treatment arms.
Comparison of 30 days intra-hospital mortality in both arms.
Measured: 30 days intra-hospital mortality
Secondary outcomes (4)
Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups.
Measured: 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).
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.
Measured: up to 24 hours
Comparison of septic shock incidence in both arms.
To compare the manifestation of septic shock (hemodynamics instability not responding to fluid administration, which requires norepinephrine infusion to maintain MAP ≥ 65 mmHg);
Measured: up to 30 days
Number of ICU-Free days.
To compare ICU free days in both groups.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJan 2016
- Primary completion1 Jan 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asta Maculiene, Lithuanian University of Health Sciences
- Investigators
- Andrius Macas, profesor, Study chair, Lithuanian university of health sciencies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846948
- Sponsor's protocol ID
- MIP051/2015
- Acronym
- ECHOCARD
- Status last verified
- Nov 2018
- First submitted
- 25 Jul 2016
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
- ClinicalTrials.gov ID
- NCT02846948
- Acronym / sponsor ID
- ECHOCARD / MIP051/2015
- Conditions
- Sepsis, Hypovolemia, Peritonitis
- Keywords
- sepsis, echocardiography, urgent, abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Focused assessed echocardiographyThe extended cardiac monitoring by focused assessed transthoracic echocardiography is applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused assessed echocardiographyFocused 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. | Other | Focussed echocardiography group |
Primary outcome
Inpatient mortality in both treatment arms.
Time frame: 30 days intra-hospital mortality
Comparison of 30 days intra-hospital mortality in both arms.
4 secondary outcomes
Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
Time frame: 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).
Time frame: up to 24 hours
Comparison of septic shock incidence in both arms.
Time frame: up to 30 days
Number of ICU-Free days.
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrius Macas, profesor study chair
Lithuanian university of health sciencies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused assessed echocardiography in people with Sepsis and Hypovolemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatient mortality in both treatment arms. (time frame: 30 days intra-hospital mortality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.