TrialX
Image

Non-invasive Stroke Volume-based uid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia

Non-invasive Stroke Volume-based uid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia

Recruiting
60 years and older
All
Phase N/A

Overview

The study is going to be a single-centre prospective randomized trial. Patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV) algorithm with the use of Nexfin monitor. Primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. Secondary outcomes included the incidence of intraoperative hypotensive episodes (with MAP<65mmHg) in both groups and the requirement of vasoactive drugs to support blood pressure

Description

The study is going to be a single-centre prospective randomized trial in elderly patients undergoing hip fracture surgery under spinal anesthesia.

Patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV) algorithm with the use of Nexfin monitor.

In patients of the control group management of the hemodynamic status will be performed in the discretion of the attending anesthesiologist, with the aim of keeping mean arterial pressure (MAP) > 65mmHg. The type and amount of delivered fluids, and vasoactive or inotropic drugs will be recorded.

In Goal Directed Fluid Therapy group, fluid management will be guided by the Nexfin monitor, based on stroke volume of the patient under continuous tracking. Baseline SV will be measured after the patients will be turned to left/right position (at which they are going to stay throughout the whole procedure) and before the implementation of regional anesthesia. Fluid challenges of 250 ml will be repeated until the SV fails to increase by 10%. At this point, preload is considered optimized and SV optimum iss defined. SV trigger is defined as SV opt - 10%. After obtaining these values, the anesthetic and surgical interventions could proceed. During surgery, N/S 250ml boluses will be administered when SV is below SV trigger. Inotropic drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if CO is below 3.5 L/min and vasopressors (phenylephrine bolus doses of 50-100mcg) if SV and CO are within the target range but MAP is below 65mmHg.

Primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. Secondary outcomes included the incidence of intraoperative hypotensive episodes (with MAP<65mmHg) in both groups and the requirement of vasoactive drugs to support blood pressure

Eligibility

Inclusion Criteria:

  • Patients scheduled for hip fracture repair
  • over 60 years of age
  • American Society of Anesthesiologists (ASA) physical status II, III, IV

Exclusion Criteria:

  • refusal or inability to consent,
  • a plan for general anesthesia
  • expected unreliable measurements of nexfin monitor (e.g. peripheral vascular disease, finger edema).

Study details
    Fluid Management
    Haemodynamic Instability

NCT04423224

Attikon Hospital

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.