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

NCT05674253 | Unknown Early Phase 1 DMC

• 1 other identifier: FMASU R 261/2022
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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)

Conditions

Atrial Fibrillation New Onset

Keywords

Atrial Fibrillation; Coronary artery bypass grafting; Dexmedetomidine; Hydrocortisone

Outcome Measures

Primary Outcomes (1)

• Occurrence of AF

  The occurrence of an episode of AF postoperatively

  Up to 7 days Postoperative

Secondary Outcomes (6)

• ICU stay

  Up to 7 days Postoperative

• Hospital stay

  Up to 10 days Postoperative

• Bradycardia

  Up to 2 days Postoperative

• Hypotension

  Up to 2 days Postoperative

• Hyperglycemia

  Up to 7 days Postoperative

Study Arms (2)

Dexmedetomidine + Hydrocortisone group

ACTIVE COMPARATOR

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

Standard group

NO INTERVENTION

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

Interventions

Dexmedetomidine + Hydrocortisone DRUG

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

Dexmedetomidine + Hydrocortisone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Scheduled for CABG Surgery with cardiopulmonary bypass (CPB) pump

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Cardiothoracic Academy, Ain Shams University Hospitals

Cairo, 11566, Egypt

RECRUITING

Related Publications (13)

• Shen J, Lall S, Zheng V, Buckley P, Damiano RJ Jr, Schuessler RB. The persistent problem of new-onset postoperative atrial fibrillation: a single-institution experience over two decades. J Thorac Cardiovasc Surg. 2011 Feb;141(2):559-70. doi: 10.1016/j.jtcvs.2010.03.011.

  PMID: 20434173 BACKGROUND

• Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039.

  PMID: 28369234 BACKGROUND

• Liu C, Wang J, Yiu D, Liu K. The efficacy of glucocorticoids for the prevention of atrial fibrillation, or length of intensive care unite or hospital stay after cardiac surgery: a meta-analysis. Cardiovasc Ther. 2014 Jun;32(3):89-96. doi: 10.1111/1755-5922.12062.

  PMID: 24495440 BACKGROUND

• Philip I, Berroeta C, Leblanc I. Perioperative challenges of atrial fibrillation. Curr Opin Anaesthesiol. 2014 Jun;27(3):344-52. doi: 10.1097/ACO.0000000000000070.

  PMID: 24633361 BACKGROUND

• Narisawa A, Nakane M, Kano T, Momose N, Onodera Y, Akimoto R, Kobayashi T, Iwabuchi M, Okada M, Miura Y, Kawamae K. Dexmedetomidine sedation during the nighttime reduced the incidence of postoperative atrial fibrillation in cardiovascular surgery patients after tracheal extubation. J Intensive Care. 2015 May 30;3(1):26. doi: 10.1186/s40560-015-0092-5. eCollection 2015.

  PMID: 26060574 BACKGROUND

• Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015 Jul;75(10):1119-30. doi: 10.1007/s40265-015-0419-5.

  PMID: 26063213 BACKGROUND

• Ueki M, Kawasaki T, Habe K, Hamada K, Kawasaki C, Sata T. The effects of dexmedetomidine on inflammatory mediators after cardiopulmonary bypass. Anaesthesia. 2014 Jul;69(7):693-700. doi: 10.1111/anae.12636. Epub 2014 Apr 28.

  PMID: 24773263 BACKGROUND

• January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Jul 9;74(1):104-132. doi: 10.1016/j.jacc.2019.01.011. Epub 2019 Jan 28. No abstract available.

  PMID: 30703431 BACKGROUND

• Leung L, Lee LHN, Lee B, Chau A, Wang EHZ. The safety of high-dose dexmedetomidine after cardiac surgery: a historical cohort study. Can J Anaesth. 2022 Mar;69(3):323-332. doi: 10.1007/s12630-021-02167-z. Epub 2021 Dec 29.

  PMID: 34966972 BACKGROUND

• Al-Shawabkeh Z, Al-Nawaesah K, Anzeh RA, Al-Odwan H, Al-Rawashdeh WA, Altaani H. Use of short-term steroids in the prophylaxis of atrial fibrillation after cardiac surgery. J Saudi Heart Assoc. 2017 Jan;29(1):23-29. doi: 10.1016/j.jsha.2016.03.005. Epub 2016 Apr 7.

  PMID: 28127215 BACKGROUND

• Church TJ, Haines ST. Treatment Approach to Patients With Severe Insulin Resistance. Clin Diabetes. 2016 Apr;34(2):97-104. doi: 10.2337/diaclin.34.2.97.

  PMID: 27092020 BACKGROUND

• Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.

  PMID: 31054241 BACKGROUND

• Alhadidy MA, Alansary AM, Elghareeb SH. Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Clinical Trial. Semin Cardiothorac Vasc Anesth. 2025 Dec;29(4):284-290. doi: 10.1177/10892532251338374. Epub 2025 Apr 27.

  PMID: 40289414 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dexmedetomidine; Hydrocortisone; hydrocortisone hemisuccinate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: December 25, 2022
• Primary Completion: June 25, 2023
• Study Completion: July 25, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)