An Early Phase 1 interventional study of Dexmedetomidine + Hydrocortisone in Atrial Fibrillation New Onset, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by Ain Shams University · Early Phase 1, Interventional, and Prevention
Atrial fibrillation (AF) occurs in 20% to 40% of patients after Coronary artery bypass grafting (CABG) and is associated with numerous detrimental sequelae. In postoperative period, the patient may be exposed to several proarrhythmogenic factors as increased endogenous catecholamines, inflammatory and oxidative mediators secondary to surgical stress and the systemic response to cardiopulmonary bypass, use of inotropic support. Steroids suppress the release of the above-mentioned inflammatory mediators. Dexmedetomidine is sympatholytic, along with anti-inflammatory properties. so combined use of both drugs may have synergistic effect to prevent post operative AF (POAF)
Postoperative atrial fibrillation (POAF) is a common postoperative complication that occurs in 20% to 40% of patients after Coronary artery bypass grafting (CABAG) and is associated with numerous detrimental sequelae.
POAF is an independent predictor of numerous adverse outcomes, including a 2- to 4-fold increased risk of stroke, reoperation for bleeding, infection, renal or respiratory failure, cardiac arrest, cerebral complications, need for permanent pacemaker placement, and a 2-fold increase in all-cause 30-day and 6-month mortality.
Clinical efforts to prevent and manage POAF following cardiac surgery have thus far presented a major challenge and results have been less than optimal. Despite numerous trials examining prophylactic and treatment modalities, POAF incidence following cardiac surgery has not changed over the past several decades.
The pathogenesis of POAF is incompletely understood but likely involves interplay between pre-existing physiological components and local and systemic inflammation. cardiopulmonary bypass and ischemia/reperfusion injury triggers generalized response characterized by leukocyte and complement activation, high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators. These mediators, such as interleukins-6 and -8, tumor necrosis factors, leukotriene B4, and tissue plasminogen activator, might contribute to many postoperative complications including atrial fibrillation (AF).
Because of the known physiologic effects of steroids to suppress the release of the above-mentioned inflammatory mediators, steroids might have beneficial effects in decreasing postoperative AF, and inhibiting the inflammatory process post cardiopulmonary bypass. Moreover, they decrease capillary wall permeability, preventing migration of inflammatory mediators into the systemic circulation. Also, Corticosteroids decrease the heterogeneity of atrial conduction and reduce inflammation following cardiac surgery, and studies have shown that preoperative prophylactic corticosteroids reduced POAF incidence without an increased rate of postoperative infection.
Dexmedetomidine is a very specific intravenously and short-acting alpha-2 agonist which theoretically reduces the sympathetic output by decreasing serum levels of norepinephrine and inhibits the release of cytokines and results in reduction of the incidence of tachycardia, inflammation, high blood pressure during and after surgery. Dexmedetomidine reduces heart rate and consequently improves myocardial oxygen demand. It also depresses sinus node and atrial ventricular nodal function which, along with the drug's anti-inflammatory properties, makes dexmedetomidine a reasonable prophylactic drug for postoperative atrial fibrillation.
So, the investigators that combined use of both drugs will have synergistic effect to prevent (POAF) after (CABG) surgery.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 248 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive dexmedetomidine 0.7 ɥg/kg/hr IV infusion before aortic cross-clamping, and will be continued intra-operatively and in ICU till weaning from mechanical ventilation Patients also will also receive Hydrocortisone 100 mg intravenous (IV) before aortic cross-clamping then 100 mg every 8 hours after surgery which will be continued for 48 hours .
Drug: Dexmedetomidine + Hydrocortisone
Patients will not receive dexmedetomidine nor Hydrocortisone and will receive the standard management
Patients will receive dexmedetomidine 0.7 ɥg/kg/hr IV infusion before aortic cross-clamping, and will be continued intra-operatively and in ICU till weaning from mechanical ventilation Patients also will also receive Hydrocortisone 100 mg intravenous (IV) before aortic cross-clamping then 100 mg every 8 hours after surgery which will be continued for 48 hours
Also known as: Medrelaxmidine + Solu-cortef
Occurrence of AF
The occurrence of an episode of AF postoperatively
Time frame: Up to 7 days Postoperative
ICU stay
length of ICU stay in days
Time frame: Up to 7 days Postoperative
Hospital stay
length of hospital stay in days
Time frame: Up to 10 days Postoperative
Bradycardia
Occurrence of Bradycardia defined as: HR≤50 bpm
Time frame: Up to 2 days Postoperative
Hypotension
Occurrence of Hypotension defined as decrease in systolic blood pressure \>20%of basal
Time frame: Up to 2 days Postoperative
Hyperglycemia
Occurrence of Uncontrolled hyperglycemia Defined as insulin requirement \>1 units/kg/day or \> 100 units/day of insulin to keep RBS \< 180 mg/dL
Time frame: Up to 7 days Postoperative
Wound infection
The occurrence of Wound infection postoperatively
Time frame: Up to 2 weeks Postoperative
Plan to share: No
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University