Control Mean Arterial Pressure in the Intensive Care Unit

NCT04639037 | Completed

• 1 other identifier: APHP200709
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized controlled trial is to compare two different strategies of postoperative mean arterial pressure (MAP) management (manual versus automated) in patients who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care unit for postoperative care. The investigators hypothesis is that the automated group will spend more time in a predetermined target MAP range of 80-90 mmHg compared to the manual group.

Conditions

Hypotension

Keywords

Intraoperative hypotension; intensive care unit; hemodynamic management

Outcome Measures

Primary Outcomes (1)

• Percentage of treatment time with a mean arterial pressure within 80-90 mmHg

  Percentage of treatment time in target (defined as a mean arterial pressure within 80-90 mmHg)

  at DAY 0

Secondary Outcomes (6)

• Percentage of treatment time in hypertension (MAP > 90 mmHg)

  at DAY 0

• Percentage of treatment time in hypotension (MAP < 80 mmHg)

  at DAY 0

• Percentage of treatment time in hypotension (MAP < 65 mmHg)

  at DAY 0

• Volume of fluid during the treatment time

  at DAY 0

• Amount of vasopressor used during the treatment time

  at DAY 0

Other Outcomes (2)

• mean Stroke volume index during the treatment time

  at DAY 0

• mean Cardiax index during the treatment time

  at DAY 0

Study Arms (2)

Manual adjustment of vasopressor

ACTIVE COMPARATOR

Fluid and vasopressor will be managed as standard practice guided by the EV1000 monitoring device (manually infusion of both fluid and vasopressors) Objective being to maintain MAP within a target MAP range of 80-90 mmHg (fluid will be optimized and stroke volume index will be maintained within normal values)

Device: Manual adjustment of vasopressor

Automated adjustment of vasopressor

EXPERIMENTAL

Fluid will be managed using the EV1000 monitoring in order to optimize stroke volume index and vasopressor will be automatically deliver by a closed-loop system to maintain the MAP within the target range of 80-90 mmHg

Device: Automated adjustment of vasopressor

Interventions

Automated adjustment of vasopressor DEVICE

The objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration)

Automated adjustment of vasopressor

Manual adjustment of vasopressor DEVICE

Fluid and vasopressor will be delivered as standard of care (manual adjustment of both fluid and vasopressor infusion rate by the nurse)

Manual adjustment of vasopressor

Eligibility Criteria

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

You may qualify if:

• Adult Patients (\>18 years)
• Patients in the intensive care or post-anesthesia care unit after a major surgery and requiring norepinephrine infusion to maintain a MAP of 80-90 mmHg.
• Patients equipped with an advanced hemodynamic monitoring device as standard of care during the surgery.
• Patient with a social security number

You may not qualify if:

• Patients refusing to participate

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University of California, Irvine: collaborator
• University of California, Los Angeles: collaborator
• Erasme University Hospital: collaborator

Study Sites (2)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

Paul Brousse Hospital

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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

Model Details: Active comparator (manual adjustment of vasopressor infusion) and Experimental (automated management of vasopressor infusion)

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 20, 2020
• Study Start: January 8, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

FR (2)