Impact Of Antioxidant Micronutrients On Intensive Care Un... | NCT00515736

Studies
Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome

NCT00515736

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Terminated

Last Update Posted

Jul 30, 2010Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Critically Ill Patients
Cardiac Surgery
Trauma
Subarachnoid Hemorrhage

Interventions

Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

enrollment was completed

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2010

Last Update Posted Date

Jul 30, 2010Estimated

Name	Class
Fresenius Kabi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are depleted particularly in those patients with intense inflammatory response. The hypothesis tested is that early I:V: administration of a combination of AOX micronutrient supplements (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill patients, by reinforcing the endogenous AOX defenses and reducing organ failure.

Detailed Description

Prospective randomized, double-blind, placebo-controlled, single-center trial. Patients admitted to ICU after complicated cardiac surgery, major trauma with or without brain injury, subarachnoid hemorrhage, and predicted by the clinicians to require >48 hours of ICU treatment.

Supplements: provided IV for 5 days

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AOX group	Experimental	Treatment group - double dose (loading) for 48 hours then single dose (Se 270 mcg, Zn 30 mg, vit C 1.2 g, B1 100 mg, vit E 300 mg enteral)	Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
0	Placebo Comparator	Group receiving vehicle solution for 5 days (double dose for 48 hours)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E	Drug	Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg	AOX group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Organ function (SOFA) with special additional attention to renal function		3 months

Secondary Outcomes

Measure	Description	Time Frame
Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients admitted for above diagnosis assessed on admission by the medical team likely to require more than 48 hours of ICU

Exclusion Criteria:

absence of consent, participation in another study, liver cirrhosis or major burns and life expectancy < 24 hours or a lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the 48 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette M Berger, MD PhD	Dpt of Adult Intensive Care, CHUV	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt of Adult Intensive Care - CHUV		Lausanne	Canton of Vaud	1011	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18687132	Result	Berger MM, Soguel L, Shenkin A, Revelly JP, Pinget C, Baines M, Chiolero RL. Influence of early antioxidant supplements on clinical evolution and organ function in critically ill cardiac surgery, major trauma, and subarachnoid hemorrhage patients. Crit Care. 2008;12(4):R101. doi: 10.1186/cc6981. Epub 2008 Aug 7.

ID	Term
D014947	Wounds and Injuries
D013345	Subarachnoid Hemorrhage
D016638	Critical Illness

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D012643	Selenium
D015032	Zinc
D001205	Ascorbic Acid
D013831	Thiamine
D014810	Vitamin E
D012996	Solutions

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D008903	Minerals
D019216