Fluid ManagementAttikonHSVNCT04423224
Non-invasive Stroke Volume-based fluid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia
A study testing GDFM in people with Fluid Management and Haemodynamic Instability, run by Attikon Hospital at 2 sites in Greece.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fluid Management, Haemodynamic Instability
- What is being tested?
- GDFM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGreece
- Study dates
- 15 Jan 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for hip fracture repair
- over 60 years of age
- American Society of Anesthesiologists (ASA) physical status II, III, IV
Who cannot join
- refusal or inability to consent,
- a plan for general anesthesia
- expected unreliable measurements of nexfin monitor (e.g. peripheral vascular disease, finger edema).
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
2nd Department of Anaesthesiology, Attikon Hospital, 1 Rimini str.
Athens, Attica, 12462
CHRYSANTHI BATISTAKI, MD, PhD, +302105832371, chrysabatistaki@yahoo.gr
- Recruiting
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462
Chrysanthi Batistaki, MD, PhD, 0030 210 5832371, chrysabatistaki@yahoo.gr
About this study
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
Read the 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
- Conditions
- Fluid Management, Haemodynamic Instability
- Being tested
- GDFM, USUAL CARE - CONTROL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDFMOther
Stroke volume variation fluid management
USUAL CARE - CONTROLOther
Usual care fluid management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: GDFM |
What is being measured
The primary outcome is the main question the study is designed to answer.
days of hospitalization after surgery
days of hospitalization after the operation
Measured: 30 days
complications
incidence of complications
Measured: 30 days
Secondary outcomes (2)
hypotension
incidence of hypotensive episodes (MAP < 65mmHg)
Measured: during surgery
use of vasoactive agents
use of vasoactive agents (phenylephrine, dopamine) exact dose
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Jan 2018
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysanthi Batistaki, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423224
- Sponsor's protocol ID
- AttikonHSV
- Acronym
- AttikonHSV
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Stroke Volume-based fluid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT04423224
- Acronym / sponsor ID
- AttikonHSV / AttikonHSV
- Conditions
- Fluid Management, Haemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: USUAL CARE - CONTROLControl 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. |
| GDFM | Active comparator | Other: GDFMGoal-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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for hip fracture repair
- over 60 years of age
- American Society of Anesthesiologists (ASA) physical status II, III, IV
Key exclusion criteria (3 listed)
- refusal or inability to consent,
- a plan for general anesthesia
- expected unreliable measurements of nexfin monitor (e.g. peripheral vascular disease, finger edema).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDFMStroke volume variation fluid management | Other | GDFM |
| USUAL CARE - CONTROLUsual care fluid management | Other | Control group |
Primary outcome
days of hospitalization after surgery
Time frame: 30 days
days of hospitalization after the operation
complications
Time frame: 30 days
incidence of complications
2 secondary outcomes
hypotension
Time frame: during surgery
use of vasoactive agents
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDFM in people with Fluid Management and Haemodynamic Instability, run by Attikon Hospital at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHRYSANTHI BATISTAKI (00302105832371, chrysabatistaki@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days of hospitalization after surgery (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020; AzTrials last refreshed its copy on 30 Oct 2026.