Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Iron Sucrose in Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544828
Recruitment Status : Unknown
Verified September 2015 by Tae-Yop Kim, MD PhD, Konkuk University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2015
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Brief Summary:
The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb arthroplasty surgery.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Iron Sucrose 200mg Drug: placebo Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Intraoperative Intravenous Iron Sucrose Enhance Postoperative Oxygenation Profile in Total Arthroplasty Surgery?
Study Start Date : November 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Osteoarthritis

Arm Intervention/treatment
Experimental: Experimental group
Iron Sucrose 200mg
Drug: Iron Sucrose 200mg
Iron Sucrose 200mg is administered after anesthesia induction.

Placebo Comparator: Control Group
placebo
Drug: placebo
placebo (normal saline) is administered after anesthesia induction
Other Name: normal saline




Primary Outcome Measures :
  1. arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio) [ Time Frame: postoperative 24 hour ]
    Intergroup-difference in PaO2/FiO2 ratio


Secondary Outcome Measures :
  1. arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio) [ Time Frame: postoperative 2 hour ]
    intergroup-difference in PaO2/FiO2 ratio

  2. arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio) [ Time Frame: postoperative 48 hour ]
    intergroup-difference in PaO2/FiO2 ratio

  3. serum hemoglobin concentration [ Time Frame: postoperative 2 hour ]
    serum hemoglobin concentration, g/dL

  4. postoperative transfusion red blood cell amount [ Time Frame: postoperative 24 hour ]
    postoperative transfusion of packed red blood cell, ml



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
  • Patients provided a written informed consent.
  • Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female)
  • Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female)
  • Patients with PaO2/FiO2 ratio >150

Exclusion Criteria:

  • Patients with history of anaphylaxis, iron overload, active infection.
  • Patients with endocrine disease
  • Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544828


Contacts
Layout table for location contacts
Contact: Tae-Yop Kim, MD, PhD 82-2-2030-5445 taeyop@gmail.com

Sponsors and Collaborators
Konkuk University Medical Center

Layout table for additonal information
Responsible Party: Tae-Yop Kim, MD PhD, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02544828     History of Changes
Other Study ID Numbers: KUH1160093
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
Osteoarthritis
knee arthroplasty
iron
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Iron
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics