The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

NCT03260309 | Completed DMC

• 1 other identifier: VilniusU
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The efficiency of semi-closed loop infusion system

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

  Before the surgery and 12 hrs postoperatively

Secondary Outcomes (7)

• Perioperative blood loss

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

• Coagulation activity

  Before (baseline) the surgery and 24hrs postoperatively

• Infused fluid and red blood cell volume

  Before the surgery and 24hrs postoperatively

• Wound healing

  Within 6 days postoperatively

• Dosage physical exercise sample

  Within 6 days postoperatively

Study Arms (2)

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.

Procedure: Semi-closed loop infusion system tactic.

control group

EXPERIMENTAL

Routine infusion therapy tactic

Procedure: Routine infusion therapy tactic

Interventions

Semi-closed loop infusion system tactic. 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.

semi-closed system group

Routine infusion therapy tactic PROCEDURE

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

control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vilnius University: lead
• Karolinska Institutet: collaborator
• Kaunas University of Technology: collaborator

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andrijauskas Audrius, PhD

  Vilnius University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Audrius Andrijauskas PhD , principal investigator, clinical professor

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: August 24, 2017
• Study Start: October 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08