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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03713008
Other study ID # CART
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2018
Est. completion date March 30, 2019

Study information

Verified date October 2019
Source Medical University of Warsaw
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. Reliability of several invasive measurements used for this purpose for many years have been questioned recently. The study will evaluate consistency between carotid artery flow derivatives and standard haemodynamic measurement (LIDCO rapid) in navigation of intraoperative fluid therapy.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Major abdominal surgery

- Artery catheter required

Exclusion Criteria:

- Laparoscopic surgery

- Known history of carotid endarterectomy

- Known history of carotid stenosis

- Non-sinus rhythm

- Systolic or diastolic heart failure

- Chronic kidney disease

- Pulmonary hypertension

- Carotid artery anomaly

- Unable to visualise carotid artery

- Angle of correction > 60

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Fluid bolus
All patients included in the study will receive 5 ml/kg fluid bolus of a balanced crystalloid solution.

Locations

Country Name City State
Poland Medical University Of Warsaw Warsaw Mazovian

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cardiac output A measure of change of scaled cardiac output (nCO) with LiDCO device Before and 2 minutes after intervention
Primary Change in a corrected carotid artery flow Ultrasound measure of corrected carotid artery flow time Before and 2 minutes after intervention
Secondary Change in pulse pressure variation A measure of change of pulse pressure variation (PPV) with LiDCO device Before and 2 minutes after intervention
Secondary Change in stroke volume variation A measure of change of pulse pressure variation with LiDCO device Before and 2 minutes after intervention
Secondary Change in a carotid blood flow Ultrasound measure of corrected carotid blood flow time Before and 2 minutes after intervention
Secondary Change in a velocity time integral of carotid flow Ultrasound measure of velocity time integral of carotid flow Before and 2 minutes after intervention
Secondary Change in the maximal systolic carotid velocity variation Ultrasound measure of the maximal systolic carotid velocity variation Before and 2 minutes after intervention
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