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Impact of intravenous iron therapy on outcomes and exercise performance in cardiac surgical patients

Impact of treating iron deficiency with intravenous iron therapy during prehabilitation period on outcomes and exercise performance in cardiac surgical patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071951
Enrollment
Unknown
Registered
2023-05-30
Start date
2018-07-02
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

Single dose intravenous iron isomaltoside group:N/A
No intravenous iron therapy group:N/A

Sponsors

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The inclusion criteria will be adults scheduled for elective cardiac surgery within 3-10 weeks with written informed consent, irrespective of their haemoglobin and iron status. We will recruit 460 consecutive patients undergoing major elective coronary artery bypass graft and/or valve surgery of anticipated duration of more than three hours.

Exclusion criteria

Exclusion criteria: We will exclude patients undergoing aortic dissection repair due to the intrinsic high risk of bleeding with this type of operation; emergency cardiac surgery; family or personal history of haemochromatosis; known reasons for anaemia, such as vitamin B12 or folate deficiency, haemoglobinopathy, thalassemia, chronic renal failure; previous intravenous iron therapy or blood transfusion in last 12 weeks; known hypersensitivity to intravenous iron therapy; body temperature more than 37.5°C or receiving non-prophylactic antibiotics; chronic liver disease and/or alanine aminotransferase or aspartate aminotransferase concentration above three times the upper limit of normal; history of asthma, allergic eczema or other atopic allergy; and rheumatoid arthritis with symptoms or signs of active inflammation.

Design outcomes

Primary

MeasureTime frame
Prevalence of anaemia and iron deficiency;Exercise performance;Days (alive and) at home within 30 days of surgery;—

Secondary

MeasureTime frame
Units of perioperative allogenic blood transfused;Chinese Veterans Specific Activity Questionnaire ;Cardiac Postoperative Morbidity Survey ;Quality of Recovery-15 item ;World Health Organization Disability Assessment Schedule 2.0;—

Countries

China

Contacts

Public ContactKing Wai YAU

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

derekyaukw@link.cuhk.edu.hk+852 3505 1912

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026