Individualized Fluid And Vasopressor Administration In Surgical Patients

NCT03965793 | Completed

• 1 other identifier: APHP190369
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative complications incidence

  at DAY 30

Study Arms (2)

Manual management of hypotension

ACTIVE COMPARATOR

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

Automated management of hypotension

EXPERIMENTAL

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

Interventions

Automated management of hypotension DEVICE

Fluid and vasopressor will be administered based on a novel automated clinical decision support system.

Automated management of hypotension; Manual management of hypotension

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicetre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

Study Officials

• Alexandre Joosten, MD PhD

  Bicetre hospital, APHP.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: October 27, 2019
• Primary Completion: July 26, 2020
• Study Completion: July 26, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)