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CompletedNCT03260309Updated Aug 28, 2017

The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

An interventional study of Semi-closed loop infusion system tactic. and Routine infusion therapy tactic in Hip Osteoarthritis, sponsored by Vilnius University. Completed. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-08-28.

Sponsored by Vilnius University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Hip Osteoarthritis

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03

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    semi-closed system group

    Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.

    Procedure: Semi-closed loop infusion system tactic.

  • Experimental
    control group

    Routine infusion therapy tactic

    Procedure: Routine infusion therapy tactic

Interventions

  • ProcedureSemi-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.

  • ProcedureRoutine infusion therapy tactic

    Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.

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What researchers measure

Primary outcomes

  1. The efficiency of semi-closed loop infusion system

    Determine the ratio of doctor's approved and rejected computer suggestions

    Time frame: Before the surgery and 12 hrs postoperatively

Secondary outcomes

  1. Perioperative blood loss

    Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume

    Time frame: Before (baseline) the surgery,during surgery and 24hrs postoperatively

  2. Coagulation activity

    Coagulation activity is investigated thromboelastically

    Time frame: Before (baseline) the surgery and 24hrs postoperatively

  3. 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

    Time frame: Before the surgery and 24hrs postoperatively

  4. Wound healing

    Evaluation of wound tissue condition, measurement of drainage fluid volume

    Time frame: Within 6 days postoperatively

  5. Dosage physical exercise sample

    Timed up and go test

    Time frame: Within 6 days postoperatively

  6. Haemodynamic stability

    Invasive measurement of arterial blood pressure

    Time frame: Before (baseline) the surgery and 12 hrs postoperatively

  7. Complications

    Registration of all complications

    Time frame: Within 6 days postoperatively

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03260309
Lead sponsor
Vilnius University
Collaborators
Karolinska Institutet, Kaunas University of Technology
Responsible party
Darius Cincikas (Audrius Andrijauskas PhD , principal investigator, clinical professor, Vilnius University) — Principal investigator
First posted
Aug 24, 2017
Start date
Oct 2013
Primary completion
Jun 2017
Completion
Jul 2017
Last update
Aug 28, 2017

Study contacts

Andrijauskas Audrius, PhD
principal investigator · Vilnius University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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