CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

Summary

Red blood cells contain a chemical called haemoglobin which carries oxygen from the lungs around the body. When the amount of haemoglobin is reduced, a patient is 'anaemic'. Anaemia can have many causes, but affects about a third of patients having major surgery in hospital. After their operation these anaemic patients are more likely to suffer serious complications. This may be because the body needs extra oxygen - and so enough haemoglobin - to heal and recover successfully from the trauma of surgery.

For a similar reason, patients' overall fitness before surgery is very important. Less fit patients are much more likely to get complications after surgery. To help us assess the risk of complications, the investigators measure patients' fitness before surgery using a cycling exercise test. The investigators monitor a number of things that show us how well the heart, the lungs and the muscles respond when they are under stress. People who are very anaemic tend to perform less well on this cycling test.

Anaemia is often due to a lack of iron, which helps make haemoglobin. Usually people get iron from foods such as red meat and spinach. Some conditions mean that patients lose iron, such as a tumour bleeding. Other illnesses make it difficult for the body to absorb iron from the gut in the first place. Both lead to a state of low iron in the body and eventually this leads to anaemia. One way to treat anaemia quickly before surgery is to give iron into the bloodstream (intra-venous). It is thought that this might reduce the risk of complications after surgery, but it is not known whether this is because it improves overall fitness, or for other reasons.

The investigators plan to carry out a study called CAPOEIRA-I (CArdio PulmOnary Exercise testing and IntRAvenous Iron) to find out whether giving patients intravenous iron improves their fitness. The investigators will measure this by doing a cycle exercise test before and then at least 10 days after the iron is given. The investigators will also measure how much the total amount of haemoglobin chnages with iron treatment. Intravenous iron is already routinely used for these patients, so the only additional activity for the study is the extra exercise test, some extra blood tests and the measurement of haemoglobin after the iron has taken effect.

Conditions

• Anemia
• Anemia, Iron Deficiency

Interventions

DRUG

MonoFer

Anaemic patients undergoing major surgery who would routinely be receiving intravenous iron 'MonoFer' will get this as part of routine care. They will then have a CPET repeated at least 10 days afterwards.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• University of Bayreuth

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• James Plumb, BMBS · University of Southampton

Eligibility

Min Age

16 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-02

Primary Completion

2018-10-01

Completion

2018-10-01

Countries

• United Kingdom

Study Locations