Phase 2
N=200
Efficacy of Enteral Iron Supplementation in Critical Illness
Anemic, Critically Ill Patients
Bottom Line
View on ClinicalTrials.gov: NCT00450177 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Hematocrit — 29.3; 29.1; 28.6; 28.2 percentage of RBC in blood
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ferrous Sulfate (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematocrit |
29.3; 29.1; 28.6; 28.2; 29.2; 28.1 | — |
| PRIMARY Serum Iron Concentration |
35; 37; 34; 34; 34; 40 | — |
| PRIMARY Serum Ferritin Concentration |
280; 265; 268; 268; 251; 355 | — |
| PRIMARY Erythrocyte Zinc Protoporphyrin Concentration |
69; 67; 75; 77; 86; 91 | — |
| SECONDARY Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital |
29; 46 | 0.03 sig |
| SECONDARY Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission |
45; 48 | — |
| SECONDARY Instance of Drug-related Constipation Throughout Hospital Admission |
12; 9 | — |
| SECONDARY Average Number of Days That Subjects Were Taking Antibiotics |
14; 16 | — |
| SECONDARY Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital |
9; 10 | — |
| SECONDARY Average Length of Stay in the Hospital |
14; 16 | — |
Summary
The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplementation and risk of infection.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Anemia (Hemoglobin 5 days
Exclusion Criteria
- Active bleeding
- Chronic inflammatory disease
- End-stage renal disease
- Hematologic disorders
- Macrocytic anemia
- Current use of erythropoietin
- Pregnancy
- Prohibition of RBC transfusions
- Moribund state in which death is imminent
- Enrollment in another clinical trial
Data sourced from ClinicalTrials.gov (NCT00450177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.