Evaluation of Corticosteroid in Systemic Inflammatory Response Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-11-01

Brief Summary

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Cardiac surgery and cardiopulmonary bypass (CPB) initiate a whole-body systemic inflammatory response (SIRS) characterized by the activation of leukocytes, monocytes, and the complement cascade. Multiple mediators of the inflammatory process are released, including cytokines, endothelin, adhesion molecules, and oxygen free radicals. An exaggerated release of these mediators may contribute to numerous postoperative end-organ complications, including myocardial dysfunction, neurologic impairment, respiratory failure, altered renal and hepatic function, bleeding disorders, and multiple organ failure. Although most cardiac surgical patients do not experience major adverse events, it is likely that the inflammatory response impairs clinical recovery to some degree in all patients.

A large number of therapeutic strategies have been developed to attenuate the inflammatory reaction to CPB and thereby enhance recovery of the cardiac surgical patient. Intraoperative corticosteroid administration has been studied extensively as a primary pharmacologic anti-inflammatory treatment option.

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Detailed Description

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Investigations have shown that clinical outcomes have been improved, worsened, or unaffected by the intraoperative administration of dexamethasone or methylprednisolone Limited data suggest that low-dose corticosteroids may be as effective as high-dose treatment in reducing complications but with fewer potential side effects MicroRNAs (miRNAs) are protein regulators that play an important role in a wide range of cellular functions. There is increasing evidence for the close relationship between miRNA expression, Th17 cell differentiation and disease pathology The miRNA, miR-155, which was the subject of this study, has a range of known biological functions, which include the induction of Toll like receptor (TLR) activation in monocytes /macrophages and the modulation of TLR signaling, facilitating pro-inflammatory cellular responses and initiating systemic inflammatory responses, as well as regulating Treg cell differentiation, maintenance, and function. The expression of this miRNA can be induced by inflammatory cytokines, such as tumor necrosis factor α (TNFα), that are released into the circulation in the initial stages of a systemic inflammatory response. In another study, demonstrated that miR-155 enhanced Treg and Th17 cell differentiation and Th17 cell function by targeting (suppressor of cytokine signaling 1) SOCS1.

In this study, the investigators will compare effect of low dose intra-operative corticosteroid (dexamethasone and methylprednisolone) as anti-inflammatory modulators through detection of T regulatory cells(Tregs) and IL-17 and correlate relation between Treg, IL-17 and micro RNA-155.

Conditions

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Systemic Inflammatory Response Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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dexamethasone group

this group will receive Dexamethasone: 0.1 to 0.3 mg/kg as single intra-operative dose and blood samples will be obtained from central venous blood at following time points: immediately after insertion during anesthetic induction (T1), 48hrs post-operative (T2), 72hrs post-operative (T3).

Group Type ACTIVE_COMPARATOR

Dexamethasone phosphate

Intervention Type DRUG

intravenous solution for injection

methylprednisolone group

this group will receive Methylprednisolone: 5-10mg/kg as single intra-operative dose and blood samples will be obtained from central venous blood at following time points: immediately after insertion during anesthetic induction (T1), 48hrs post-operative (T2), 72hrs post-operative (T3).

Group Type ACTIVE_COMPARATOR

solumedrol

Intervention Type DRUG

intravenous solution for injection

Interventions

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solumedrol

intravenous solution for injection

Intervention Type DRUG

Dexamethasone phosphate

intravenous solution for injection

Intervention Type DRUG

Other Intervention Names

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methylprednisolone dexamethasone

Eligibility Criteria

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Inclusion Criteria

* open heart surgery with Cardiopulmonary bypass machine with relatively long bypass time more than 60 minute
* All patients Included in study with normal heart function

Exclusion Criteria

* Left ventricular ejection fraction less than 40%
* acute infection such as sepsis or pneumonia, hepatic and renal failure, cancer or any autoimmune disease
* the use of steroid within 2 week prior to operation
* coagulation abnormalities

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes