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Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01296074
Enrollment
30
Registered
2011-02-15
Start date
2011-03-31
Completion date
2011-08-31
Last updated
2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases, Systemic Inflammatory Response Syndrome

Keywords

monocyte, cardiopulmonary bypass, cardiac surgery

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.

Interventions

DRUGCorticosteroid

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

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Valve replacement under cardiopulmonary bypass

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
recovery of monocyte subsetsbaseline, day1, 3, 5, 7 postoperativeChanges in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026