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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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."

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04996420
• Other study ID #: Emospin 2
• Status: Terminated
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: November 22, 2020

Study information

• Verified date: July 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 22, 2020
• Est. primary completion date: November 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 50-80 years

• ASA I, II or III

• primary elective hip arthroplasty

Exclusion Criteria:

• spinal anesthesia contraindications

• periferical vasculopaty

• other diseases which indicates better an invasive monitoring by radial artery cannulation

• atrial fibrillation

• denial or inability to provide informed consent

Related Conditions & MeSH terms

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

Intervention

Device:
• Clearsight non invasive hemodynamic monitoring
Goal directed fluid therapy fuided by Clearsight monitoring

Locations

Country	Name	City	State
Italy	IORizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total perioperative hypotension time defined by a mean arterial pressure < 65mmHg, from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room (i.e. up to 8 hours)		from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room