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

Primary Purpose

Fluid Management, Haemodynamic Instability

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
GDFM
USUAL CARE - CONTROL
Sponsored by
Attikon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluid Management

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

GDFM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

days of hospitalization after surgery
days of hospitalization after the operation
complications
incidence of complications

Secondary Outcome Measures

hypotension
incidence of hypotensive episodes (MAP < 65mmHg)
use of vasoactive agents
use of vasoactive agents (phenylephrine, dopamine) exact dose

Full Information

First Posted
June 5, 2020
Last Updated
June 5, 2020
Sponsor
Attikon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04423224
Brief Title
Non-invasive Stroke Volume-based fluid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia
Acronym
AttikonHSV
Official Title
Non-invasive Stroke Volume-based fluid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Management, Haemodynamic Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
GDFM
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
GDFM
Intervention Description
Stroke volume variation fluid management
Intervention Type
Other
Intervention Name(s)
USUAL CARE - CONTROL
Intervention Description
Usual care fluid management
Primary Outcome Measure Information:
Title
days of hospitalization after surgery
Description
days of hospitalization after the operation
Time Frame
30 days
Title
complications
Description
incidence of complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
hypotension
Description
incidence of hypotensive episodes (MAP < 65mmHg)
Time Frame
during surgery
Title
use of vasoactive agents
Description
use of vasoactive agents (phenylephrine, dopamine) exact dose
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHRYSANTHI BATISTAKI
Phone
00302105832371
Email
chrysabatistaki@yahoo.gr
Facility Information:
Facility Name
2nd Department of Anaesthesiology, Attikon Hospital, 1 Rimini str.
City
Athens
State/Province
Attica
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHRYSANTHI BATISTAKI, MD, PhD
Phone
+302105832371
Email
chrysabatistaki@yahoo.gr
Facility Name
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrysanthi Batistaki, MD, PhD
Phone
0030 210 5832371
Email
chrysabatistaki@yahoo.gr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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