The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

NCT ID: NCT03260309

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-07-31

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.

Conditions

Hip Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Semi-closed loop infusion system tactic.

Intervention Type: PROCEDURE

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.

control group

Routine infusion therapy tactic

Group Type: EXPERIMENTAL

Routine infusion therapy tactic

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Routine infusion therapy tactic

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Kaunas University of Technology

OTHER

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Darius Cincikas

Audrius Andrijauskas PhD , principal investigator, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrijauskas Audrius, PhD

Role: PRINCIPAL_INVESTIGATOR

Vilnius University

Other Identifiers

VilniusU

Identifier Type: -

Identifier Source: org_study_id