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Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset AF After CABG Surgery

Primary Purpose

Atrial Fibrillation New Onset

Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine + Hydrocortisone
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation New Onset focused on measuring Atrial Fibrillation, Coronary artery bypass grafting, Dexmedetomidine, Hydrocortisone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Scheduled for CABG Surgery with cardiopulmonary bypass (CPB) pump Exclusion Criteria: History of heart block. Patients with preoperative bradycardia (HR < 60 / min) Patients with preoperative hypotension (systolic blood pressure < 90 mmhg) Previous episodes of AF or flutter. Uncontrolled diabetes mellitus requiring insulin treatment with recent hyperglycemia which required hospital treatment. History of peptic ulcer disease. Active systemic bacterial or mycotic infection. Permanent pacemaker. Any documented or suspected supraventricular or ventricular arrhythmias. Urgent or emergency surgery. Planned off-pump surgery. Patient Refusal.

Sites / Locations

  • Cardiothoracic Academy, Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Dexmedetomidine + Hydrocortisone group

Standard group

Arm Description

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 .

Patients will not receive dexmedetomidine nor Hydrocortisone and will receive the standard management

Outcomes

Primary Outcome Measures

Occurrence of AF
The occurrence of an episode of AF postoperatively

Secondary Outcome Measures

ICU stay
length of ICU stay in days
Hospital stay
length of hospital stay in days
Bradycardia
Occurrence of Bradycardia defined as: HR≤50 bpm
Hypotension
Occurrence of Hypotension defined as decrease in systolic blood pressure >20%of basal
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
Wound infection
The occurrence of Wound infection postoperatively

Full Information

First Posted
December 30, 2022
Last Updated
January 9, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05674253
Brief Title
Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset AF After CABG Surgery
Official Title
Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2022 (Actual)
Primary Completion Date
June 25, 2023 (Anticipated)
Study Completion Date
July 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset
Keywords
Atrial Fibrillation, Coronary artery bypass grafting, Dexmedetomidine, Hydrocortisone

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine + Hydrocortisone group
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Standard group
Arm Type
No Intervention
Arm Description
Patients will not receive dexmedetomidine nor Hydrocortisone and will receive the standard management
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine + Hydrocortisone
Other Intervention Name(s)
Medrelaxmidine + Solu-cortef
Intervention Description
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
Primary Outcome Measure Information:
Title
Occurrence of AF
Description
The occurrence of an episode of AF postoperatively
Time Frame
Up to 7 days Postoperative
Secondary Outcome Measure Information:
Title
ICU stay
Description
length of ICU stay in days
Time Frame
Up to 7 days Postoperative
Title
Hospital stay
Description
length of hospital stay in days
Time Frame
Up to 10 days Postoperative
Title
Bradycardia
Description
Occurrence of Bradycardia defined as: HR≤50 bpm
Time Frame
Up to 2 days Postoperative
Title
Hypotension
Description
Occurrence of Hypotension defined as decrease in systolic blood pressure >20%of basal
Time Frame
Up to 2 days Postoperative
Title
Hyperglycemia
Description
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
Title
Wound infection
Description
The occurrence of Wound infection postoperatively
Time Frame
Up to 2 weeks Postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Scheduled for CABG Surgery with cardiopulmonary bypass (CPB) pump Exclusion Criteria: History of heart block. Patients with preoperative bradycardia (HR < 60 / min) Patients with preoperative hypotension (systolic blood pressure < 90 mmhg) Previous episodes of AF or flutter. Uncontrolled diabetes mellitus requiring insulin treatment with recent hyperglycemia which required hospital treatment. History of peptic ulcer disease. Active systemic bacterial or mycotic infection. Permanent pacemaker. Any documented or suspected supraventricular or ventricular arrhythmias. Urgent or emergency surgery. Planned off-pump surgery. Patient Refusal.
Facility Information:
Facility Name
Cardiothoracic Academy, Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
University President
Phone
+2026847819
Email
gd.research@asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Adel Mohamed Alansary, MD
First Name & Middle Initial & Last Name & Degree
Sara Hamdy Elghareeb, MD
First Name & Middle Initial & Last Name & Degree
Mohamed A. Alhadidy, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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20434173
Citation
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Citation
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Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset AF After CABG Surgery

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