Obesity, Anemia, Iron Deficiencies, Bariatric Surgery
Conditions
Brief summary
This study aimed to explore the effects of preoperative intravenous isomaltose iron supplementation versus placebo on postoperative Hb improvement, prevention of postoperative anemia, and improvement in quality of life in patients undergoing bariatric surgery.
Interventions
DRUGIron Isomaltoside injection
Patients in the isomaltan iron group received intravenous isomaltan iron dissolved in 250 ml of normal saline 3 days prior to surgery. The patients' iron requirements were calculated using a simplified scale, with a maximum single dose of 20 mg/kg. If the dose was insufficient in a single administration, a second infusion was required every other week. The placebo group received an equal volume of 0.9% normal saline. Simplified scale: Hemoglobin (g/L) patient weight \<50kg 50-70kg \>70kg ≥100 500mg 1000mg 1500mg \<100 500mg 1500mg 2000mg
At the same time point, the same dose of physiological saline was infused as the experimental group.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ① Baseline Hb: Men 10-14 g/dL, Women 10-13 g/dL; ② Iron deficiency: Serum ferritin (SF) \<100 μg/L, and transferrin saturation (TSAT) \<20%; ③ BMI \>30 kg/m2.
Exclusion criteria
* ① Known severe hypersensitivity reactions to other parenteral iron supplements; ② Mean corpuscular volume (MCV) \> 100 fL; ③ Received intravenous iron infusion within the past 3 months; ④ Concurrent tumors; ⑤ Concurrent iron overload or other hematologic disorders; ⑥ Concurrent infectious diseases such as hepatitis B; ⑦ Moderately impaired liver function: decompensated cirrhosis or hepatitis, ALT, AST \> 3 × upper limit of normal (ULN); ⑧ Concurrent acute or chronic infections, heart failure, or other diseases affecting iron metabolism; ⑨ Patients with stage 3 or higher chronic renal insufficiency: glomerular filtration rate (eGFR) \< 60 ml/min; ⑩ Pregnant or lactating women; ⑪ Acute infections, rheumatoid arthritis, or significant joint inflammation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in Hb concentration compared to baseline | 3 months post-surgery, |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of anemia | 3 months, 6 months and 12 months after surgery |
| Iron metabolism indicators (serum ferritin, serum iron, total iron binding capacity, transferrin saturation) | 3 months, 6 months, and 12 months post-surgery |
| The proportion of patients requiring re-treatment for iron deficiency anemia within 12 months post-surgery (Hb < 11 g/dL, SF < 30 μg/L, or SF < 100 μg/L and TSAT < 20%). | 12 months post-surgery |
Countries
China
Contacts
Primary ContactNianrong Zhang Zhang
Outcome results
None listed