Anemia, Iron-deficiency, Patient Blood Management, Iron Deficiency Anemia
Conditions
Keywords
handgrip strength, intravenous iron
Brief summary
This is a sub-study parallel to ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery (NCT03888768). Only female participants of ProPBM will be included in this sub-study. Association between anaemia and handgrip strength and the effect of intravenous iron therapy as part of ProPBM protocol within female participants is elucidated in this study.
Detailed description
BACKGROUND: Maximal physical efforts and aerobic exercise depend highly on adequate oxygen supply provided by haemoglobin and level of iron bound to haemoglobin. Handgrip strength has been shown to have a strong validity and high reliability in testing the upper body and lower body muscle strength, however its use as a potential tool to identify early anaemic patients planned for surgery is not fully explored. To our knowledge, this study is the first to investigate the diagnostic power of functional performance test within preoperative anaemic population and the change of handgrip strength after administration of intravenous iron. METHODS: At recruitment of ProPBM study, all eligible patients for this sub-study will be invited to this sub-study and have their full blood count, ferritin and transferrin saturation recorded and handgrip strength assessed. After randomization, those within the ProPBM protocol will receive IV iron therapy as indicated. Participants who are randomized to standard care will follow usual medical management. Participants will be admitted 1 day prior to surgery. On admission, preoperative bloods and handgrip strength will be repeated for patients who were randomized into the ProPBM arm.
Interventions
The strength of the dominant hand will be recorded before and after receiving intravenous iron. Each participant will be positioned in a straight back chair with both hand and feet flat on the ground, elbow flexed to 90 degrees with forearm and wrist in the neutral position. Patient's muscle strength will then be tested three times with an interval of one minute between testing and the average of three times will be recorded to the nearest 0.1kg.
Sponsors
Ministry of Health, Malaysia
University of Malaya
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients participating in the ProPBM study * Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics surgery * The patient must be willing and able to provide informed consent for the study
Exclusion criteria
* Patients with known muscle weakness eg myasthenia gravis * Patients with cerebrovascular or orthopaedic disease that could influence muscle mass and/or upper body function * Patients in which IV iron is contraindicated eg 1st trimester of pregnancy or known allergy or hypersensitivity to parenteral iron * Patients with iron overload
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between handgrip strength and haemoglobin status within female participants of ProPBM study | At recruitment | The dependent variable is concentration of plasma circulating haemoglobin (Hb) taken at recruitment and measured in g/dL. The non-dependant variable is the baseline handgrip strength recorded in kilogram using Jamar hydraulic hand dynamometer. Participants will be positioned in a straight back chair with both hand and feet flat on the ground, elbow flexed to 90 degrees with forearm and wrist in the neutral position. Patient's muscle strength will then be tested three times with an interval of one minute between testing and the average of three times will be recorded to the nearest 0.1kg. The association between anaemia and handgrip strength will be analyzed by using binary logistic regression technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between handgrip strength and iron status within female participants of ProPBM study | At recruitment | Iron status is measured by ferritin level (mcg/L) and transferrin saturation (percentage value). Association between iron status and handgrip strength will be analysed using a linear regression technique. |
| Change in handgrip strength in iron deficient female participants of ProPBM study who received intravenous iron | Handgrip strength repeated within 1 month post IV iron administration preoperatively | Participants who received intravenous iron will have their ferritin level, TSAT and handgrip strength reassesed during preoperative admission. Handgrip strength after IV iron administration will be compared to baseline handgrip strength. |
Countries
Malaysia
Contacts
Primary ContactUniversity of Malaya Medical Centre Jalan Universiti
Outcome results
None listed