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

Haemodynamic Instability Clinical Trial

— AttikonHSV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423224
• Other study ID #: AttikonHSV
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2020
• Source: Attikon Hospital
• Contact: CHRYSANTHI BATISTAKI
• Phone: 00302105832371
• Email: chrysabatistaki[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

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).

Related Conditions & MeSH terms

• Fluid Management
• Haemodynamic Instability
• Hip Fractures

Intervention

Other:
• GDFM
Stroke volume variation fluid management
• USUAL CARE - CONTROL
Usual care fluid management

Locations

Country	Name	City	State
Greece	2nd Department of Anaesthesiology, Attikon Hospital, 1 Rimini str.	Athens	Attica
Greece	2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days of hospitalization after surgery	days of hospitalization after the operation	30 days
Primary	complications	incidence of complications	30 days
Secondary	hypotension	incidence of hypotensive episodes (MAP < 65mmHg)	during surgery
Secondary	use of vasoactive agents	use of vasoactive agents (phenylephrine, dopamine) exact dose	during surgery