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

NCT03346213 | Completed

• 1 other identifier: CRI
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiopulmonary exercise testing; Intravenous iron; Total haemoglobin mass

Outcome Measures

Primary Outcomes (1)

• Change from baseline in oxygen consumption at anaerobic threshold (VO2AT) measured in mls/kg/min

  Using cardiopulmonary exercise testing (CPET) to assess the oxygen consumption at anaerobic threshold before and then after intravenous iron therapy.

  Up to 6 weeks

Secondary Outcomes (8)

• Change from baseline in peak oxygen consumption (VO2peak) measured in mls/kg/min

  Up to 6 weeks

• Change from baseline haemoglobin concentration [Hb] measured in grams per litre (g.l-1)

  Up to 6 weeks

• Change from baseline in total haemoglobin mass measured in grams

  Up to 6 weeks

• Change form baseline in hepcidin assay measured in nanograms per millilitre (ng/ml)

  Up to 6 weeks

• Change form baseline in serum ferritin measured in micrograms per litre

  Up to 6 weeks

Other Outcomes (13)

• Change from baseline- Creatinine

  Up to 6 weeks

• Change from baseline- Calcium

  Up to 6 weeks

• Change from baseline- Platelet count

  Up to 6 weeks

Study Arms (1)

Major surgery

1. Adult patients undergoing elective surgery 2. Having a CPET as part of routine care 3. Patients with a Hb value of \< 130 g/L who are iron deficient, iron restricted/deplete or have functional iron deficiency. 4. Able to provide written informed consent.

Drug: MonoFer

Interventions

MonoFer DRUG

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.

Major surgery

Eligibility Criteria

• Age: 16 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This cohort is composed of patients attending University Hospital Southampton NHS Foundation trust for major surgery who are found to be anaemic as part of routine clinical screening and are deemed suitable for intravenous iron therapy by the clinical team.

You may qualify if:

• Adult patients undergoing elective surgery
• Having a CPET as part of routine care
• Patients with a Hb value of \< 130 g/L who are iron deficient, iron restricted/deplete or have functional iron deficiency as described in 5.2 and Appendix 1
• Able to provide written informed consent.
• Patients with mixed aetiology anaemia who are either iron deficient, iron replete or functionally iron deficient alongside B12 or folate deficiency will be eligible for the study alongside treatment of their other nutritional deficiency.

You may not qualify if:

• Pregnant women
• Prisoners
• Hypersensitivity to the active substance, to 'Monofer' (iron isomaltoside 1000) or any of its excipients
• Known documented serious hypersensitivity to any parenteral iron products
• Haemochromatosis or other iron overload states
• Acute liver or renal failure
• Active infection
• Those receiving a blood transfusion between the CPET tests
• Unable/ contraindication to perform CPET (Appendix 3)
• Haemoglobinopathies such as Sickle Cell Anaemia or Thalassemia
• Other cause for anaemia such as haematological malignancy, haemolysis, hypothyroidism.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University College, London: collaborator
• University of Bayreuth: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation trust

Southampton, England, SO16 6YD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma stored in freezers at University Hospital Southampton

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• James Plumb, BMBS

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 17, 2017
• Study Start: February 2, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)