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Individualized Fluid And Vasopressor Administration In Surgical Patients (INFIVASP)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965793
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk patients undergoing major abdominal and orthopedic surgery (manual versus automated) The investigators hypothesis is that the automated group will spend less time during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to the manual group.

Condition or disease Intervention/treatment Phase
Intraoperative Hypotension Device: Automated management of hypotension Not Applicable

Detailed Description:

The maintenance of MAP is essential for organ perfusion pressure. Intraoperative hypotension is a frequent complication both after induction and during maintenance of anaesthesia, ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to the occurrence of a systemic inflammatory response syndrome and is a key determinant of postoperative complications. Persistent intraoperative hypotension has been reported as an important prognostic factor of postoperative morbidity and mortality. Adequate treatment of arterial hypotension is therefore of particular importance during surgery. However, the avoidance of hypotension includes the infusion of vasopressor and/or fluid to optimize perfusion pressure. The manual adjustment of vasopressor administration has been shown to be suboptimal.

Recently, a paper published in the JAMA journal demonstrated that among patients undergoing high-risk surgery, the maintenance of blood pressure within 10% of patient's baseline systolic blood pressure resulted in less postoperative organ dysfunction compared to standard MAP management.

Today, the investigators have an automated clinical decision support system that help ease the administration of both fluid and vasopressors during surgery (individualized fluid and vasopressor administration). The department of the investigators has recently implemented a manual hemodynamic protocol to optimize fluid and vasopressor. The goal is to maintain stroke volume index within 90% of the optimal stroke volume via mini fluid challenge of crystalloid solution (100 ml) following the French guidelines and to maintain MAP within 90 % of patient's baseline MAP. This protocol has been called : Individualized Fluid and vasopressor protocol (because based on patient's values) The purpose of this study is therefore to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk surgical patients (manual versus automated and decision support guided) The investigators hypothesis is that automated group will spend less time during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to the manual group because patient's stroke volume and MAP will be better maintained during surgery (within 10% of patient' targets).The decision support system will remind the clinician when to administer a bolus of fluid to maintain stroke volume index within 10% of the optimize stroke volume index value and an automated closed-lopp system will titrate norepinephrine to keep MAP within 10% of patient's MAP target. The study will thus compare an individualized hemodynamic protocol (already in place in our institution) applied manually to a decision support-and closed-loop guided- individualized hemodynamic protocol (intervention group).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Individualized Fluid and Vasopressor Administration in Surgical Patients: A Randomized Controlled Trial
Actual Study Start Date : October 25, 2019
Actual Primary Completion Date : June 26, 2020
Actual Study Completion Date : June 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Manual management of hypotension
Fluid and vasopressor will be managed as standard practice ( manually infusion of both fluid and vasopressors) following the investigators manual individualized hemodynamic protocol.(objective being to keep both stroke volume and MAP within 90 % of the target values)
Device: Automated management of hypotension
Fluid and vasopressor will be administered based on a novel automated clinical decision support system.

Experimental: Automated management of hypotension
Fluid and vasopressor will be managed with a novel active clinical decision support system to guide fluid administration and automated closed-loop system to maintain MAP within 90% of patient' baseline.
Device: Automated management of hypotension
Fluid and vasopressor will be administered based on a novel automated clinical decision support system.




Primary Outcome Measures :
  1. Percentage of surgery time in hypotension [ Time Frame: at day 1 ]
    Percentage of surgery time in hypotension (defined as the percentage of case time the patient will spend with a MAP < 10% of patient's MAP Baseline)


Secondary Outcome Measures :
  1. Postoperative complications incidence [ Time Frame: at DAY 30 ]
    Number of postoperative complications at day 30 post surgery among the 9 items (postoperative nausea and vomiting, delirium, wound infection, urinary infection, pneumonia, acute kidney injury incidence, paralytic ileus, other infections, readmission to hospital within the 30 days post surgery



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients scheduled for major abdominal and orthopedic surgery equipped with a cardiac output monitoring device.

Exclusion Criteria:

  • Patients < 18 years old
  • cardiac arrythmia (atrial fibrillation)
  • Pregnant woman

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 ClinicalTrials.gov identifier (NCT number): NCT03965793


Locations
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France
Bicetre Hospital
Le Kremlin-Bicêtre, France, 94270
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Alexandre Joosten, MD PhD Bicetre hospital, APHP.
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03965793    
Other Study ID Numbers: APHP190369
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases