Clinical trial NCT06309641: Methemoglobinemia Following Intravenous Iron Treatment
Official title: Methemoglobinemia Following Intravenous Iron Treatment Administered As Ferric Carboxymaltose or Ferric Derisomaltose in Patients with Anemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Methemoglobinemia
Anemia
Iron Deficiencies
Side Effect
Keywords: Intravenous iron
ferric carboxymaltose
ferric derisomaltose
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults (age ≥ 18 years) with anemia that are scheduled for administration of intravenous iron (ferric carboxymaltose or ferric derisomaltose) in the region of Dalarna, Sweden.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in methemoglobin after ferric derisomaltose
timeFrame: 30-120 minutes after start of iron administration
measure: Difference in methemoglobin after ferric carboxymaltose
timeFrame: 30-120 minutes after start of iron administration
Secondary outcomes:
measure: Difference in methemoglobin depending on drug dosage
timeFrame: 30-120 minutes after start of iron administration
measure: Difference in methemoglobin depending on age
timeFrame: 30-120 minutes after start of iron administration
measure: Difference in methemoglobin depending on sex
timeFrame: 30-120 minutes after start of iron administration
measure: Difference in methemoglobin depending on hemoglobin level before treatment
timeFrame: 30-120 minutes after start of iron administration
measure: Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron.
timeFrame: 30-120 minutes after start of iron administration
measure: Association between difference in methemoglobin and venous lactate
timeFrame: 30-120 minutes after start of iron administration
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Center of Clinical Research Dalarna
Study officials:
References: