NCT04996420

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

Goal Directed Fluid Management vs Liberal Fluid Regimen Based on Mean Arterial Pressure in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty: a Randomized, Prospective, Controlled Study."

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Clearsight non invasive hemodynamic monitoring	Goal directed fluid therapy fuided by Clearsight monitoring

Timeline

• Start date: 2019-05-22
• Primary completion: 2020-11-22
• Completion: 2020-11-22
• First posted: 2021-08-09
• Last updated: 2023-06-01

Locations

1 site across 1 country: Italy