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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02846948 |
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Date of registration:
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25/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
ECHOCARD |
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Scientific title:
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The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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131 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02846948 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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Andrius Macas, profesor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lithuanian university of health sciencies |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypovolemia
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Sepsis
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Peritonitis
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Intervention(s)
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Other: Focused assessed echocardiography
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Primary Outcome(s)
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Inpatient mortality in both treatment arms.
[Time Frame: 30 days intra-hospital mortality]
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Secondary Outcome(s)
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Number of ICU-Free days.
[Time Frame: up to 30 days]
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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]
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Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
[Time Frame: 1-5 minutes after anaesthesia induction.]
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Comparison of septic shock incidence in both arms.
[Time Frame: up to 30 days]
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Secondary ID(s)
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MIP051/2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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