Hip OsteoarthritisNCT03260309
The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes
A study testing Semi-closed loop infusion system tactic. and Routine infusion therapy tactic in people with Hip Osteoarthritis, run by Vilnius University.
Trial summary
Success of the hip arthroplasty depends on the measures that optimize perioperative conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Semi-closed loop infusion system tactic. and Routine infusion therapy tactic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jul 2017
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal - epidural anesthesia
- Age >50 and <85 years
- ASA (American Society of Anesthesiology Classification) II physical status
- Start of operation no later than 09:00
- Signed informed consent form
Who cannot join
- Age <50 and >85 yers
- BMI (Body Mass Index) <20 and >40 kg/m2
- ASA I and ASA>II physical status
- History of a bleeding disorder
- Anemia before surgery Hb<110 g/l
- Intravascular fluid infusion within 24 hours before study
Show all 17Show fewer
- Diabetes mellitus
- Previous open hip surgery
- Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
- Alcohol intake 5 U daily
- Contraindication to spinal - epidural anesthesia
- Surgery not by project surgeon
- Start of operation later than 09:00
- Atrial fibrillation
- Narcotic addiction
- History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
- Participation in the other study
About this study
Official title: The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes
Success of the hip arthroplasty depends on the measures that optimize perioperative conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.
Read the detailed description
Success of the total hip arthroplasty depends on the measures that optimize perioperative conditions. They increase the emotional stress of the staff and error probability. It is planned to evaluate semi-closed loop infusion system, its adaption for infusion application's influence to near and far treatment outcomes done by prospective randomized clinical trial. This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed loop system's influence on the doctor's emotional tension during the decision making.
- Conditions
- Hip Osteoarthritis
- Being tested
- Semi-closed loop infusion system tactic., Routine infusion therapy tactic
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-closed loop infusion system tactic.Procedure or surgery
Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.
Routine infusion therapy tacticProcedure or surgery
Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.
| Study group | Role | What they receive |
|---|---|---|
| semi-closed system group | Experimental | Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion. Receives: Procedure: Semi-closed loop infusion system tactic. |
| control group | Experimental | Routine infusion therapy tactic Receives: Procedure: Routine infusion therapy tactic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficiency of semi-closed loop infusion system
Determine the ratio of doctor's approved and rejected computer suggestions
Measured: Before the surgery and 12 hrs postoperatively
Secondary outcomes (7)
Perioperative blood loss
Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume
Measured: Before (baseline) the surgery,during surgery and 24hrs postoperatively
Coagulation activity
Coagulation activity is investigated thromboelastically
Measured: Before (baseline) the surgery and 24hrs postoperatively
Infused fluid and red blood cell volume
Repeated rehydration bolus (sol.Ringeri 2,5ml/kg), supportive fluid infusion (sol.NaCl 0,9% 1,5 ml/kg/hrs); evaluation of signs of anemia intolerance if Hb < 110 g/l
Measured: Before the surgery and 24hrs postoperatively
Wound healing
Evaluation of wound tissue condition, measurement of drainage fluid volume
Measured: Within 6 days postoperatively
Dosage physical exercise sample
Timed up and go test
Measured: Within 6 days postoperatively
Haemodynamic stability
Invasive measurement of arterial blood pressure
Measured: Before (baseline) the surgery and 12 hrs postoperatively
Complications
Registration of all complications
Measured: Within 6 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startOct 2013
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Kaunas University of Technology
- Responsible party
- Principal investigator, Darius Cincikas, Vilnius University
- Investigators
- Andrijauskas Audrius, PhD, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260309
- Sponsor's protocol ID
- VilniusU
- Status last verified
- Aug 2017
- First submitted
- 29 Feb 2016
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes
- ClinicalTrials.gov ID
- NCT03260309
- Acronym / sponsor ID
- VilniusU
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Kaunas University of Technology
- Study start
- Oct 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Aug 2017 (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.
Success of the hip arthroplasty depends on the measures that optimize perioperative conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.
Detailed description
Success of the total hip arthroplasty depends on the measures that optimize perioperative conditions. They increase the emotional stress of the staff and error probability. It is planned to evaluate semi-closed loop infusion system, its adaption for infusion application's influence to near and far treatment outcomes done by prospective randomized clinical trial. This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed loop system's influence on the doctor's emotional tension during the decision making.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semi-closed system group | Experimental | Procedure: Semi-closed loop infusion system tactic.Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion. |
| control group | Experimental | Procedure: Routine infusion therapy tacticRoutine infusion therapy tactic |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal - epidural anesthesia
- Age >50 and <85 years
- ASA (American Society of Anesthesiology Classification) II physical status
- Start of operation no later than 09:00
- Signed informed consent form
Key exclusion criteria (17 listed)
- Age <50 and >85 yers
- BMI (Body Mass Index) <20 and >40 kg/m2
- ASA I and ASA>II physical status
- History of a bleeding disorder
- Anemia before surgery Hb<110 g/l
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 |
|---|---|---|
| Semi-closed loop infusion system tactic.Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion. | Procedure or surgery | semi-closed system group |
| Routine infusion therapy tacticRoutine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia. | Procedure or surgery | control group |
Primary outcome
The efficiency of semi-closed loop infusion system
Time frame: Before the surgery and 12 hrs postoperatively
Determine the ratio of doctor's approved and rejected computer suggestions
7 secondary outcomes
Perioperative blood loss
Time frame: Before (baseline) the surgery,during surgery and 24hrs postoperatively
Coagulation activity
Time frame: Before (baseline) the surgery and 24hrs postoperatively
Infused fluid and red blood cell volume
Time frame: Before the surgery and 24hrs postoperatively
Wound healing
Time frame: Within 6 days postoperatively
Dosage physical exercise sample
Time frame: Within 6 days postoperatively
Haemodynamic stability
Time frame: Before (baseline) the surgery and 12 hrs postoperatively
Complications
Time frame: Within 6 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Andrijauskas Audrius, PhD principal investigator
Vilnius University
Questions about this trial
What is this clinical trial studying?
A study testing Semi-closed loop infusion system tactic. and Routine infusion therapy tactic in people with Hip Osteoarthritis, run by Vilnius University.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficiency of semi-closed loop infusion system (time frame: Before the surgery and 12 hrs postoperatively). 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 28 Aug 2017.