Anemia, Iron Deficiencies, Methemoglobinemia, Side Effect
Conditions
Keywords
Intravenous iron, ferric carboxymaltose, ferric derisomaltose
Brief summary
Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose.
Detailed description
Methemoglobin is an isoform of hemoglobin without oxygen carrying properties. Higher levels of methemoglobin may impact oxygen transport of the blood and increase the risk of tissue hypoxia. Methemoglobinemia has been reported as side effect of different drugs such as antibiotics or local anesthetics, but not after iron preparations. There is only one case report of increased levels of methemoglobin following intravenous iron therapy. Patients with anemia due to iron deficiency can be treated with intravenous iron preparations such as ferric carboxymaltose or ferric derisomaltose. Anemia itself reduces oxygen transport of the blood, increasing the risk of tissue hypoxia due to methemoglobinemia in those patients. This study aims to assess methemoglobinemia following treatment with intravenous iron in patients with anemia. The report will include case reports of patients with severe anemia who developed methemoglobinemia following treatment with ferric derisomaltose. Furthermore, methemoglobin levels are evaluated before and after intravenous iron administration in a cohort of adult patients with anemia who are scheduled to receive ferric carboxymaltose or ferric derisomaltose in routine care.
Interventions
DIAGNOSTIC_TESTBlood sample after treatment
Blood samples for measurement of methemoglobin are obtained directly before and 30-120 minutes after drug administration.
OTHERCase reports
Description of clinical course and methemoglobin levels in patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose.
Sponsors
Claudia Seiler
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for patients in the cohort study: * anemia * prescription of administration of intravenous iron (ferric carboxymaltose or ferric derisomaltose) for patients in the case report: \- patients with severe anemia who developed methemoglobinemia following administration of ferric derisomaltose
Exclusion criteria
* declined consent * known or suspected methemoglobinemia of genetic or other origin * previous administration of intravenous iron within one week before study sampling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in methemoglobin after ferric derisomaltose | 30-120 minutes after start of iron administration | Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric derisomaltose. |
| Difference in methemoglobin after ferric carboxymaltose | 30-120 minutes after start of iron administration | Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric carboxymaltose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in methemoglobin depending on sex | 30-120 minutes after start of iron administration | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on sex. |
| Difference in methemoglobin depending on hemoglobin level before treatment | 30-120 minutes after start of iron administration | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on hemoglobin level before treatment. |
| Difference in methemoglobin depending on drug dosage | 30-120 minutes after start of iron administration | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on drug dosage |
| Association between difference in methemoglobin and venous lactate | 30-120 minutes after start of iron administration | Association between change of methemoglobin (percent) in venous blood and change of lactate in venous blood after compared to before treatment with intravenous iron. |
| Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron. | 30-120 minutes after start of iron administration | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on blood levels of ferritin, transferrin or iron. |
| Difference in methemoglobin depending on age | 30-120 minutes after start of iron administration | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on age. |
Countries
Sweden
Outcome results
None listed