Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-... | NCT01296074

Studies
Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

NCT01296074

Sponsor

Beijing Anzhen Hospital

Status

Completed

Last Update Posted

Oct 19, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Heart Valve Diseases
Systemic Inflammatory Response Syndrome

Interventions

Corticosteroid

Countries

China

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

Oct 2017

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

Mar 2011Actual

Primary Completion Date

Apr 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Feb 14, 2011

First Submission Date that Met QC Criteria

Feb 14, 2011

First Posted Date

Feb 15, 2011Estimated

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

Oct 17, 2017

Last Update Posted Date

Oct 19, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaotong Hou, Chief of Center for Cardiac Intensive Care, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Name	Class
National Natural Science Foundation of China	OTHER_GOV

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

To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the peripheral blood of valve disease patients undergoing cardiopulmonary bypass perioperatively.

Detailed Description

Systemic inflammatory response syndrome (SIRS) is a common major complication of cardiopulmonary bypass. "Emergency Hematopoiesis" is the pathological process induced by the inflammation. The investigators previously confirmed that emergency hematopoiesis induced by cardiopulmonary bypass led to dynamic changes of quantities of monocyte subsets, there is a significant increase in the number of two monocyte subsets: 1) CD14highCD16+ monocyte with strong immunomodulatory activity; 2) CD14lowCD16- monocyte with potential ability of proliferation and differentiation. Therefore, a new hypothesis risen: "the change of the function and the number of monocyte subsets induced by emergency hematopoiesis play an important role for SIRS occurrence after cardiopulmonary bypass, correcting emergency hematopoiesis is a new breakthrough in the prevention and treatment of SIRS." To identify the mechanism of function changed in different monocyte subsets during the pathogenesis of SIRS, the research intended to target perioperative-period patients with heart valve replacement, monitor dynamically the number and phenotype of peripheral blood monocyte subsets by flow cytometry; sort out of different monocyte subsets for cell culture in vitro, observe the ability of proliferation and differentiation and effects between monocyte subsets and T lymphocyte; investigate the mechanism of immune function changes with antibody-blocking and compartment culture in patients; observe the impact of glucocorticoid treatment on the emergency hematopoiesis, offer new objects for evaluation of immune status in patients and provide new evidence for anti-inflammatory therapy .

Patients should be follow the protocol of cardiopulmonary bypass according to normal hospital routine practice.

A total of 30 patients will be enrolled in this clinical trial.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Corticosteroid	Experimental	Methylprednisolone will be given during cardiopulmonary bypass.	Drug: Corticosteroid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Corticosteroid	Drug	500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.	Corticosteroid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recovery of monocyte subsets	Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.	baseline, day1, 3, 5, 7 postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Valve replacement under cardiopulmonary bypass

Exclusion Criteria:

Cardiopulmonary bypass time over 120 minutes
Hyperlipidemia
Diabetes mellitus
Autoimmune diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
Xiaotong Hou, M.D., Ph.D.	Beijing Anzhen Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiaotong Hou		Beijing	Beijing Municipality	100029	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19332460	Background	Ho KM, Tan JA. Benefits and risks of corticosteroid prophylaxis in adult cardiac surgery: a dose-response meta-analysis. Circulation. 2009 Apr 14;119(14):1853-66. doi: 10.1161/CIRCULATIONAHA.108.848218. Epub 2009 Mar 30.
18664462	Background	Whitlock RP, Chan S, Devereaux PJ, Sun J, Rubens FD, Thorlund K, Teoh KH. Clinical benefit of steroid use in patients undergoing cardiopulmonary bypass: a meta-analysis of randomized trials. Eur Heart J. 2008 Nov;29(21):2592-600. doi: 10.1093/eurheartj/ehn333. Epub 2008 Jul 28.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D007249	Inflammation
D010335	Pathologic Processes

ID	Term
D000305	Adrenal Cortex Hormones
D008776	Methylprednisolone Hemisuccinate

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D008775	Methylprednisolone
D011239	Prednisolone

ID	Term
D006349	Heart Valve Diseases
D018746	Systemic Inflammatory Response Syndrome