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Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty

NCT04996420 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-06-01

No results posted yet for this study

Summary

Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability.

The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring.

The primary endpoint is to evaluate total duration of hypotension, defined as a MAP \< 65 mmHg, calculated during all the perioperatory time.

Fifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen.

Conditions

  • Arthroplasty, Replacement, Hip
  • Anesthesia, Spinal
  • Hemodynamic Monitoring
  • Crystalloid Solutions

Interventions

DEVICE

Clearsight non invasive hemodynamic monitoring

Goal directed fluid therapy fuided by Clearsight monitoring

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Stefano Bonarelli, MD · Istituto Ortopedico Rizzoli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2020-11-22
Completion
2020-11-22

Countries

  • Italy

Study Locations

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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 NCT04996420 on ClinicalTrials.gov