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Post Anaesthesia Care Hypotension Prevention

NCT05844774 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension both during and after surgery (24 hrs) in adults undergoing major abdominal surgery. The main question this trial aims to answer is:

• Does the use of the hypertension prediction index (HPI) decrease hypotension during surgery and in the post-operative period?

During and after their surgery, participants in the intervention group will be treated according to the HPI-algorithm.

Participants in the control group will be treated following the standard of care.

Conditions

  • Hypotension During Surgery

Interventions

DEVICE

HPI (using HemoSphere) - guided algorithm

Treatment of hypotension guided by the hypotension prediction index. Patients will receive treatment following the predetermined HPI-algorithm when the HPI exceeds 85%.

DEVICE

Treatment of hypotension following standard of care

Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Van Eijk · Coordinating Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-22
Primary Completion
2024-06-01
Completion
2024-08-01

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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 NCT05844774 on ClinicalTrials.gov