NCT01296074

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

February 14, 2011

Last Update Submit

October 17, 2017

Conditions

Heart Valve DiseasesSystemic Inflammatory Response Syndrome

Keywords

monocytecardiopulmonary bypasscardiac surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Corticosteroid

EXPERIMENTAL

Methylprednisolone will be given during cardiopulmonary bypass.

Drug: Corticosteroid

Interventions

CorticosteroidDRUG

500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.

Also known as: Solu-Medrol
Corticosteroid

Eligibility Criteria

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

You may qualify if:

  • Valve replacement under cardiopulmonary bypass

You may not qualify if:

  • Cardiopulmonary bypass time over 120 minutes
  • Hyperlipidemia
  • Diabetes mellitus
  • Autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaotong Hou

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (4)

  • 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.

    PMID: 19332460BACKGROUND

  • 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.

    PMID: 18664462BACKGROUND

  • Bourbon A, Vionnet M, Leprince P, Vaissier E, Copeland J, McDonagh P, Debre P, Gandjbakhch I. The effect of methylprednisolone treatment on the cardiopulmonary bypass-induced systemic inflammatory response. Eur J Cardiothorac Surg. 2004 Nov;26(5):932-8. doi: 10.1016/j.ejcts.2004.07.044.

    PMID: 15519185BACKGROUND

  • Hao X, Han J, Zeng H, Wang H, Li G, Jiang C, Xing Z, Hao Y, Yang F, Hou X. The effect of methylprednisolone prophylaxis on inflammatory monocyte subsets and suppressive regulatory T cells of patients undergoing cardiopulmonary bypass. Perfusion. 2019 Jul;34(5):364-374. doi: 10.1177/0267659118820777. Epub 2019 Jan 9.

    PMID: 30624149DERIVED

MeSH Terms

Conditions

Heart Valve DiseasesSystemic Inflammatory Response Syndrome

Interventions

Adrenal Cortex HormonesMethylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsMethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xiaotong Hou, M.D., Ph.D.

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Center for Cardiac Intensive Care

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 15, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2011

Study Completion

August 1, 2011

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

CN(1)