Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Heart Valve Diseases
Systemic Inflammatory Response Syndrome

Clinical Trial Details

NCT number	NCT01296074
Study type	Interventional
Source	Beijing Anzhen Hospital
Contact
Status	Completed
Phase	N/A
Start date	March 2011
Completion date	August 2011

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT02865798` - China Senile Valvular Heart Disease Cohort Study	N/A
Completed	`NCT02249000` - BIOVALVE - I / II Clincial Investigation	N/A
Completed	`NCT02297334` - Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery	N/A
Completed	`NCT01591018` - SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry	Phase 3
Completed	`NCT01428947` - Does Coronary Angiography Cause Cognitive Dysfunction?	N/A
Recruiting	`NCT01231776` - Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass	N/A
Terminated	`NCT01116037` - ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study	N/A
Completed	`NCT00371891` - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)	Phase 4
Terminated	`NCT03632967` - Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System	N/A
Recruiting	`NCT05728047` - Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery
Not yet recruiting	`NCT05539261` - Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery
Completed	`NCT05479968` - Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
Completed	`NCT03527381` - Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery	Phase 1/Phase 2
Completed	`NCT03664102` - Automated Fastener Device Versus Manually Tied Knot in MiAVR
Recruiting	`NCT06084091` - Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
Completed	`NCT05836467` - Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?
Recruiting	`NCT05933083` - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation	N/A
Recruiting	`NCT04445012` - Cardiovascular Acoustics and an Intelligent Stethoscope
Active, not recruiting	`NCT02732691` - JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study	N/A
Completed	`NCT02981953` - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms