Individualized Fluid And Vasopressor Administration In Surgical Patients (INFIVASP)

Individualized Fluid and Vasopressor Administration in Surgical Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Hypotension
• Intervention / Treatment: Device: Automated management of hypotension

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).

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Bicetre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of surgery time in hypotension	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)	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications incidence	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	at DAY 30

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Alexandre Joosten, MD PhD, Bicetre hospital, APHP.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2019
• Primary Completion (Actual): July 26, 2020
• Study Completion (Actual): July 26, 2020

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: APHP190369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No