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

NCT04423224 | Unknown

• 1 other identifier: AttikonHSV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Fluid Management; Haemodynamic Instability

Outcome Measures

Primary Outcomes (2)

• days of hospitalization after surgery

  days of hospitalization after the operation

  30 days

• complications

  incidence of complications

  30 days

Secondary Outcomes (2)

• hypotension

  during surgery

• use of vasoactive agents

  during surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control group Management of the hemodynamic status in the control group 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.

Other: USUAL CARE - CONTROL

GDFM

ACTIVE COMPARATOR

Goal-directed fluid management group (GDFM). . Baseline SV will be measured after the patients will be turned to left/right position \& before implementation of regional anesthesia. Fluid challenges of 250 ml will be repeated until SV fails to increase by 10%. At this point, preload is considered optimized and SV optimum is defined. SV trigger is defined as SV opt - 10%. 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. Patients will be reassessed during the intraoperative period every 10 minutes . Except from the fluid boluses, all patients will be administered Ringer's lactate solution at an infusion rate of 2ml/kg/h.

Other: GDFM

Interventions

GDFM OTHER

Stroke volume variation fluid management

GDFM

USUAL CARE - CONTROL OTHER

Usual care fluid management

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (2)

2nd Department of Anaesthesiology, Attikon Hospital, 1 Rimini str.

Athens, Attica, 12462, Greece

RECRUITING

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, 12462, Greece

RECRUITING

Central Study Contacts

CHRYSANTHI BATISTAKI

CONTACT

00302105832371; chrysabatistaki@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesiology

Model Details: Control group Management of the hemodynamic status in the control group versus a goal directed group based on stroke volume variation protocol (with Nexfin monitor) in patients undergoing hip fracture fixation under spinal anesthesia

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: January 15, 2018
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

GR (2)