Trial record 14 of 286 for:    Open Studies | "Heart Valve Diseases"

Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Capital Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT01296074
First received: February 14, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Valve Diseases
Systemic Inflammatory Response Syndrome
Drug: Corticosteroid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • recovery of monocyte subsets [ Time Frame: baseline, day1, 3, 5, 7 postoperative ] [ Designated as safety issue: No ]
    Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corticosteroid
Methylprednisolone will be given during cardiopulmonary bypass.
Drug: Corticosteroid
500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.
Other Name: Solu-Medrol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Valve replacement under cardiopulmonary bypass

Exclusion Criteria:

  • Cardiopulmonary bypass time over 120 minutes
  • Hyperlipidemia
  • Diabetes mellitus
  • Autoimmune diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296074

Contacts
Contact: Xiaotong Hou, M.D., Ph.D. +8601064456838 houxiaotong@yahoo.com.cn

Locations
China, Beijing
Xiaotong Hou Not yet recruiting
Beijing, Beijing, China, 100029
Contact: Xiaotong Hou, M.D., Ph.D.    +8601064456838    houxiaotong@yahoo.com.cn   
Principal Investigator: Xiaotong Hou, M.D., Ph.D.         
Sponsors and Collaborators
Capital Medical University
National Natural Science Foundation of China
Investigators
Principal Investigator: Xiaotong Hou, M.D., Ph.D. Beijing Anzhen Hospital, Capital Medical University
  More Information

Publications:
Responsible Party: Xiaotong Hou, Beijing Anzhen Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT01296074     History of Changes
Other Study ID Numbers: 81070203
Study First Received: February 14, 2011
Last Updated: February 14, 2011
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Capital Medical University:
monocyte
cardiopulmonary bypass
cardiac surgery

Additional relevant MeSH terms:
Heart Valve Diseases
Systemic Inflammatory Response Syndrome
Heart Diseases
Cardiovascular Diseases
Inflammation
Pathologic Processes
Shock
Methylprednisolone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014