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Control Mean Arterial Pressure in the Intensive Care Unit

NCT04639037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-05-03

No results posted yet for this study

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

Interventions

DEVICE

Automated adjustment of vasopressor

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)

DEVICE

Manual adjustment of vasopressor

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

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER

  • University of California, Los Angeles

    collaborator OTHER

  • Erasme University Hospital

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2022-01-26
Completion
2022-01-26

Countries

  • France

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639037 on ClinicalTrials.gov