Anemic, Critically Ill PatientsPhase 2NCT00450177

Efficacy of Enteral Iron Supplementation in Critical Illness

A Phase 2 study testing Ferrous Sulfate in people with Anemic, Critically Ill Patients, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemic, Critically Ill Patients
What is being tested?: Ferrous Sulfate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Jan 2006to Jan 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Active bleeding
Chronic inflammatory disease
End-stage renal disease
Hematologic disorders
Macrocytic anemia
Current use of erythropoietin

Show all 10Show fewer

Pregnancy
Prohibition of RBC transfusions
Moribund state in which death is imminent
Enrollment in another clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Medical College of Cornell University
New York, New York, 10021

Other trials in United States

About this study

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness

Read the detailed description

Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoiesis into storage within the reticuloendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

Conditions: Anemic, Critically Ill Patients
Being tested: Ferrous Sulfate, Placebo Oral Tablet
Keywords: iron, critical illness, anemia, infection
Medical subject headings: Critical Illness, Anemia, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferrous SulfateDrug
Iron group
Placebo Oral TabletDrug
Placebo group

Study groups in NCT00450177
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Hematocrit
Measured: Day 7, Day 14, Day 21, Day 28
Serum Iron Concentration
Measured: Day 7, Day 14, Day 21, Day 28
Serum Ferritin Concentration
Measured: Day 7, Day 14, Day 21, Day 28
Erythrocyte Zinc Protoporphyrin Concentration
Measured: 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
Measured: Throughout hospital stay up to 6 weeks
Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission
Measured: Throughout hospital stay up to 6 weeks
Instance of Drug-related Constipation Throughout Hospital Admission
Measured: Throughout hospital stay up to 6 weeks
Average Number of Days That Subjects Were Taking Antibiotics
Measured: Throughout hospital stay up to 6 weeks
Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital
Measured: Throughout hospital stay up to 6 weeks
Average Length of Stay in the Hospital
Measured: Throughout hospital stay up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Jan 2008

First posted21 Mar 2007 (estimated)
Study startJan 2006
Primary completionDec 2007
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anemic, Critically Ill PatientsStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00450177
Sponsor's protocol ID: 052007738
Status last verified: Jul 2019
First submitted: 20 Mar 2007
Last updated: 18 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19245362

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness
ClinicalTrials.gov ID: NCT00450177
Acronym / sponsor ID: 052007738
Conditions: Anemic, Critically Ill Patients
Keywords: iron, critical illness, anemia, infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Study start: Jan 2006 (actual)
Primary completion: Dec 2007 (actual)
Study completion: Jan 2008 (actual)
First posted: 21 Mar 2007 (estimated)
Results: Posted 8 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Iron Group	Experimental	Drug: Ferrous SulfateFerrous 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.
Placebo Group	Placebo comparator	Drug: Placebo Oral TabletPlacebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

Active bleeding
Chronic inflammatory disease
End-stage renal disease
Hematologic disorders
Macrocytic anemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ferrous SulfateIron group	Drug	Iron Group
Placebo Oral TabletPlacebo group	Drug	Placebo Group

Primary outcome

Hematocrit
Time frame: Day 7, Day 14, Day 21, Day 28
Serum Iron Concentration
Time frame: Day 7, Day 14, Day 21, Day 28
Serum Ferritin Concentration
Time frame: Day 7, Day 14, Day 21, Day 28
Erythrocyte Zinc Protoporphyrin Concentration
Time frame: Day 7, Day 14, Day 21, Day 28

6 secondary outcomes

Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital
Time frame: Throughout hospital stay up to 6 weeks
Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission
Time frame: Throughout hospital stay up to 6 weeks
Instance of Drug-related Constipation Throughout Hospital Admission
Time frame: Throughout hospital stay up to 6 weeks
Average Number of Days That Subjects Were Taking Antibiotics
Time frame: Throughout hospital stay up to 6 weeks
Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital
Time frame: Throughout hospital stay up to 6 weeks
Average Length of Stay in the Hospital
Time frame: Throughout hospital stay up to 6 weeks

Results and safety

Results posted to the registry on 8 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iron Group	97	88
Placebo Group	103	92

Primary outcome: Hematocrit

Time frame: Day 7, Day 14, Day 21, Day 28. Mean (Standard Deviation). Unit: percentage of RBC in blood

Measure	Iron Group n = 97	Placebo Group n = 103
Day 7	29.3 (0.5)	29.1 (0.5)
Day 14	28.6 (0.4)	28.2 (0.5)
Day 21	29.2 (0.4)	28.1 (0.6)
Day 28	27.8 (0.6)	28.1 (0.5)

Primary outcome: Serum Iron Concentration

Time frame: Day 7, Day 14, Day 21, Day 28. Mean (Standard Deviation). Unit: mcg/mL

Measure	Iron Group n = 97	Placebo Group n = 103
Day 7	35 (0.6)	37 (0.7)
Day 14	34 (0.5)	34 (0.7)
Day 21	34 (0.6)	40 (0.6)
Day 28	37 (0.5)	36 (0.7)

Primary outcome: Serum Ferritin Concentration

Time frame: Day 7, Day 14, Day 21, Day 28. Mean (Standard Deviation). Unit: ng/mL

Measure	Iron Group n = 97	Placebo Group n = 103
Day 7	280 (46)	265 (73)
Day 14	268 (51)	268 (80)
Day 21	251 (40)	355 (83)
Day 28	383 (54)	361 (76)

Primary outcome: Erythrocyte Zinc Protoporphyrin Concentration

Time frame: Day 7, Day 14, Day 21, Day 28. Mean (Standard Deviation). Unit: micromol:mol heme

Measure	Iron Group n = 97	Placebo Group n = 103
Day 7	69 (4)	67 (5)
Day 14	75 (6)	77 (5)
Day 21	86 (5)	91 (6)
Day 28	84 (6)	89 (5)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iron Group	0 of 97 (0%)	7 of 97 (7.2%)	Not reported
Placebo Group	0 of 103 (0%)	4 of 103 (3.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19245362Pieracci 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip S Barie, MD, MBA principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ferrous Sulfate in people with Anemic, Critically Ill Patients, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematocrit (time frame: Day 7, Day 14, Day 21, Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00450177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.