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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04423224
Acronym
AttikonHSV
Enrollment
30
Registered
2020-06-09
Start date
2018-01-15
Completion date
2021-12-30
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Management, Haemodynamic Instability

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

Detailed 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

Interventions

OTHERGDFM

Stroke volume variation fluid management

OTHERUSUAL CARE - CONTROL

Usual care fluid management

Sponsors

Attikon Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
days of hospitalization after surgery30 daysdays of hospitalization after the operation
complications30 daysincidence of complications

Secondary

MeasureTime frameDescription
hypotensionduring surgeryincidence of hypotensive episodes (MAP \< 65mmHg)
use of vasoactive agentsduring surgeryuse of vasoactive agents (phenylephrine, dopamine) exact dose

Countries

Greece

Contacts

Primary ContactCHRYSANTHI BATISTAKI
chrysabatistaki@yahoo.gr00302105832371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026