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

January 9, 2023 updated by: Mohamed Alaaeldin Abdelmoneem Alhadidy, Ain Shams University

Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

248

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Recruiting
        • Cardiothoracic Academy, Ain Shams University Hospitals
        • Contact:
        • Principal Investigator:
          • Adel Mohamed Alansary, MD
        • Sub-Investigator:
          • Sara Hamdy Elghareeb, MD
        • Sub-Investigator:
          • Mohamed A. Alhadidy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine + Hydrocortisone group
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 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
Other Names:
  • Medrelaxmidine + Solu-cortef
No Intervention: Standard group
Patients will not receive dexmedetomidine nor Hydrocortisone and will receive the standard management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of AF
Time Frame: Up to 7 days Postoperative
The occurrence of an episode of AF postoperatively
Up to 7 days Postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU stay
Time Frame: Up to 7 days Postoperative
length of ICU stay in days
Up to 7 days Postoperative
Hospital stay
Time Frame: Up to 10 days Postoperative
length of hospital stay in days
Up to 10 days Postoperative
Bradycardia
Time Frame: Up to 2 days Postoperative
Occurrence of Bradycardia defined as: HR≤50 bpm
Up to 2 days Postoperative
Hypotension
Time Frame: Up to 2 days Postoperative
Occurrence of Hypotension defined as decrease in systolic blood pressure >20%of basal
Up to 2 days Postoperative
Hyperglycemia
Time Frame: Up to 7 days Postoperative
Occurrence of Uncontrolled hyperglycemia Defined as insulin requirement >1 units/kg/day or > 100 units/day of insulin to keep RBS < 180 mg/dL
Up to 7 days Postoperative
Wound infection
Time Frame: Up to 2 weeks Postoperative
The occurrence of Wound infection postoperatively
Up to 2 weeks Postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2022

Primary Completion (Anticipated)

June 25, 2023

Study Completion (Anticipated)

July 25, 2023

Study Registration Dates

First Submitted

December 30, 2022

First Submitted That Met QC Criteria

December 30, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 261/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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