Clinical trial NCT03260309: The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes
Official title: The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Kaunas University of Technology
First posted: 2017-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: The efficiency of semi-closed loop infusion system
timeFrame: Before the surgery and 12 hrs postoperatively
Secondary outcomes:
measure: Perioperative blood loss
timeFrame: Before (baseline) the surgery,during surgery and 24hrs postoperatively
measure: Coagulation activity
timeFrame: Before (baseline) the surgery and 24hrs postoperatively
measure: Infused fluid and red blood cell volume
timeFrame: Before the surgery and 24hrs postoperatively
measure: Wound healing
timeFrame: Within 6 days postoperatively
measure: Dosage physical exercise sample
timeFrame: Within 6 days postoperatively
measure: Haemodynamic stability
timeFrame: Before (baseline) the surgery and 12 hrs postoperatively
measure: Complications
timeFrame: Within 6 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Vilnius University
name: Andrijauskas Audrius, PhD
role: PRINCIPAL_INVESTIGATOR
References: