Impact of Ascorbic Acid on Post-Cardiothoracic Surgery In... | NCT00519337

Studies
Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

NCT00519337

Sponsor

Hartford Hospital

Status

Completed

Last Update Posted

Jan 5, 2012Estimated

Enrollment

25Actual

Phase

Phase 4

Conditions

Cardiac Surgery
Inflammation

Interventions

Ascorbic acid
Placebo

Countries

United States

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Apr 2011Actual

First Submitted Date

Aug 20, 2007

First Submission Date that Met QC Criteria

Aug 21, 2007

First Posted Date

Aug 22, 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

Jan 3, 2012

Last Update Posted Date

Jan 5, 2012Estimated

Name	Class
The Gustavus and Louise Pfeiffer Research Foundation	UNKNOWN

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

The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.

Detailed Description

Atrial Fibrillation is a significant cause of morbidity following cardiothoracic surgery. Despite prophylactic therapy with beta-blockers and amiodarone, post-operative atrial fibrillation occurs in approximately 22% of patients. We believe that by reducing the inflammation that is caused during CTS, we can see further improvements without any negative effects on hemodynamics. Ascorbic acid, a free radical scavenger has been found to lower inflammation mediators but never in a CTS population. This study will help determine the affect of ascorbic acid on the inflammation associated with CTS.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Ascorbic acid	Drug: Ascorbic acid
2	Placebo Comparator	Identical placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ascorbic acid	Drug	Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In CTS patients receiving standard of care therapy,evaluate the effect of ascorbic acid therapy on c-reactive protein (CRP) concentration on post-CTS day 3 and the total post-CTS systemic exposure to CRP over 4 days.		4 Postoperative Days

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the effect of high intensity versus low intensity statin therapy on blood concentrations of fibrinogen, and White blood cell count on post-CTS days 3 and the total post-CTS systemic exposure to these biomarkers over 4 days.		4 Postoperative Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiothoracic surgery

Exclusion Criteria:

Pregnancy
Prior hypersensitivity to ascorbic acid
Renal Calculi

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
C. Michael White, Pharm.D.	Hartford Hospital, University of Connecticut	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hartford Hosptial		Hartford	Connecticut	06102	United States

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided