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Trial record 14 of 667 for:    CARBON DIOXIDE AND arterial

Hemodynamic Optimization During Major Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03474224
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : April 16, 2019
Information provided by (Responsible Party):
Dr.Andrea Russo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:
In this prospective observational study investigators aim to search any relationship between the venous to arterial carbon dioxide gap and the time of percentage to adherence too a stroke volume guided protocol.

Condition or disease Intervention/treatment
Hemodynamic Instability Device: Ev1000 Clinical Platform from Edwards Lifesciences

Detailed Description:
During major abdominal surgery (i.e. cefalopancreasectomy) investigators will use a minimally hemodynamic monitoring (Flotrac Monitoring System) to guide fluid therapy; investigators will refer to a stroke volume target value obtained by a bolus of Crystalloids. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol and the venous-arterial CO2 gap.Investigators expect to find an inverse proportionality between the two parameters explored.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Venous to Arterial Carbon Dioxide Combined to a Targerting Stroke Volume Protocol During Major Abdominal Surgery
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : July 10, 2019
Estimated Study Completion Date : October 5, 2019

Group/Cohort Intervention/treatment
FloTrac patients
patients belong to this group will be managed with a stroke volume target hemodynamic protocol
Device: Ev1000 Clinical Platform from Edwards Lifesciences
The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.

Primary Outcome Measures :
  1. correlation between the stroke-volume guided fluid therapy and the carbon dioxide venous-to-arterial gap absolute value in mmHg [ Time Frame: an average of 8 hours ]
    investigators will optimize fluid therapy in order to achieve the higher value of stroke volume and will verify if the time of SV > 90% of the maximal value is correlated to a value of the carbon dioxide venous-to-arterial gap less than 6 mmHg

Secondary Outcome Measures :
  1. incidence of postoperative overall complications [ Time Frame: up to 30 days ]
    investigators will assess the impact of the intraoperative hemodynamic optimization on the rate of postoperative complications

  2. duration of hospitalization [ Time Frame: an average of 2 weeks ]
    investigators will prospectively evaluate the association between an intraoperative goal-directed fluid therapy with the long of stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for major abdominal surgery who met the above mentioned inclusion criteria will be enrolled. All patients will belong the only study group in which a target-based hemodynamic protocol will be applied

Inclusion Criteria:

  • patients scheduled for abdominal surgery
  • ASA 1-2-3

Exclusion Criteria:

  • pregnancy
  • obesity with a BMI > 35
  • controindications to central venous catheter positioning
  • end-stage renal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03474224

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Contact: laura cascarano, MD 0630154507

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Andrea Russo Recruiting
Rome, Italy, 00166
Contact: laura cascarano, MD   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Principal Investigator: Andrea Russo, MD Department of Anesthesiology

Additional Information:

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Responsible Party: Dr.Andrea Russo, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS Identifier: NCT03474224     History of Changes
Other Study ID Numbers: 1822
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr.Andrea Russo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
stroke volume
goal directed therapy
major abdominal surgery