NCT00450177

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
11.5 years until next milestone

Results Posted

Study results publicly available

July 8, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

March 20, 2007

Results QC Date

April 24, 2019

Last Update Submit

July 8, 2019

Conditions

Anemic, Critically Ill Patients

Keywords

ironcritical illnessanemiainfection

Outcome Measures

Primary Outcomes (4)

  • Hematocrit

    Day 7, Day 14, Day 21, Day 28

  • Serum Iron Concentration

    Day 7, Day 14, Day 21, Day 28

  • Serum Ferritin Concentration

    Day 7, Day 14, Day 21, Day 28

  • Erythrocyte Zinc Protoporphyrin Concentration

    Day 7, Day 14, Day 21, Day 28

Secondary Outcomes (6)

  • Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital

    Throughout hospital stay up to 6 weeks

  • Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission

    Throughout hospital stay up to 6 weeks

  • Instance of Drug-related Constipation Throughout Hospital Admission

    Throughout hospital stay up to 6 weeks

  • Average Number of Days That Subjects Were Taking Antibiotics

    Throughout hospital stay up to 6 weeks

  • Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital

    Throughout hospital stay up to 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Iron Group

EXPERIMENTAL

Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Drug: Ferrous Sulfate

Placebo Group

PLACEBO COMPARATOR

Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Drug: Placebo Oral Tablet

Interventions

Ferrous SulfateDRUG

Iron group

Iron Group
Placebo Oral TabletDRUG

Placebo group

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Anemia (Hemoglobin \< 13.0 g/dL)
  • ≤ 72 hours from hospital admission
  • Current tolerance of enteral medications
  • Expected ICU LOS \> 5 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

  • Pieracci FM, Henderson P, Rodney JR, Holena DN, Genisca A, Ip I, Benkert S, Hydo LJ, Eachempati SR, Shou J, Barie PS. Randomized, double-blind, placebo-controlled trial of effects of enteral iron supplementation on anemia and risk of infection during surgical critical illness. Surg Infect (Larchmt). 2009 Feb;10(1):9-19. doi: 10.1089/sur.2008.043.

    PMID: 19245362DERIVED

MeSH Terms

Conditions

Critical IllnessAnemiaInfections

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Philip S. Barie, MD
Organization
Weill Cornell Medical College
pbarie@med.cornell.edu
646-962-2580

Study Officials

  • Philip S Barie, MD, MBA

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

July 18, 2019

Results First Posted

July 8, 2019

Record last verified: 2019-07

Locations

US(1)