Celiprolol Versus Ditiazem for the Prevention of Postoperative Cardiac Arrythmias in Thoracic Surgery

NCT03752931 | Unknown Phase 2 DMC

• 1 other identifier: MAMICELDIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac arrythmias are the most common cardiac complications after thoracic surgery. They are made primarily of postoperative atrial fibrillation (POAF). They are associated with an increased risk of stroke, increased length of hospital stay and cost of care, and increased long-term mortality. Randomized , single-blind prospective study in the anesthesia and intensive care department of Abderrahmen Mami hospital Ariana Tunisia comparing the efficacy of Diltiazem versus Celiprolol in the prevention of postoperative cardiac arrythmias in patients proposed for pneumonectomy and bilobectomy.

Conditions

Postoperative Cardiac Complication

Keywords

Pneumonectomy Thoracic surgery Celiprolol Diltiazem

Outcome Measures

Primary Outcomes (1)

• incidence of early postoperative atrial fibrillation

  14 days

Secondary Outcomes (1)

• incidence of other cardiac arrythmias and other complications

  30 days

Study Arms (2)

Celiprolol

ACTIVE COMPARATOR

receiving 1 tablet per day of celiprolol (Celiprol®) 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks.

Drug: Celiprolol

Diltiazem

ACTIVE COMPARATOR

receiving 1 capsule per day of diltiazem (Monotildiem® LP) 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobectomy for 2 weeks.

Drug: Diltiazem

Interventions

Celiprolol DRUG

receiving 1 tablet per day of Celiprolol 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks.

Celiprolol

Diltiazem DRUG

receiving 1 tablet per day of Diltiazem 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks.

Diltiazem

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years Sinus rhythm preoperatively.
• Surgery at high risk of atrial arrhythmia occurring postoperatively:
• Bi-lobectomy
• Pneumonectomie

You may not qualify if:

• Signs of myocardial ischemia per or post operative.
• Persistent postoperative hypotension requiring the use of catecholamines.
• Persistent bradycardia
• Decompensated cardiac insufficiency.
• Acute intestinal obstruction.

Sponsors & Collaborators

• Abderrahmane Mami Hospital: lead

Study Sites (1)

Hospital Abderrahmane Mami

Aryanah, Tunisia

Location

Related Publications (3)

• Zhao BC, Huang TY, Deng QW, Liu WF, Liu J, Deng WT, Liu KX, Li C. Prophylaxis Against Atrial Fibrillation After General Thoracic Surgery: Trial Sequential Analysis and Network Meta-Analysis. Chest. 2017 Jan;151(1):149-159. doi: 10.1016/j.chest.2016.08.1476. Epub 2016 Oct 8.

  PMID: 27729264 BACKGROUND

• Fernando HC, Jaklitsch MT, Walsh GL, Tisdale JE, Bridges CD, Mitchell JD, Shrager JB. The Society of Thoracic Surgeons practice guideline on the prophylaxis and management of atrial fibrillation associated with general thoracic surgery: executive summary. Ann Thorac Surg. 2011 Sep;92(3):1144-52. doi: 10.1016/j.athoracsur.2011.06.104. No abstract available.

  PMID: 21871327 BACKGROUND

• Frendl G, Sodickson AC, Chung MK, Waldo AL, Gersh BJ, Tisdale JE, Calkins H, Aranki S, Kaneko T, Cassivi S, Smith SC Jr, Darbar D, Wee JO, Waddell TK, Amar D, Adler D; American Association for Thoracic Surgery. 2014 AATS guidelines for the prevention and management of perioperative atrial fibrillation and flutter for thoracic surgical procedures. J Thorac Cardiovasc Surg. 2014 Sep;148(3):e153-93. doi: 10.1016/j.jtcvs.2014.06.036. Epub 2014 Jun 30. No abstract available.

  PMID: 25129609 BACKGROUND

MeSH Terms

Interventions

Celiprolol; Diltiazem

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Phenylurea Compounds; Urea; Amides; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marzouk Mahmoud, MD

  Abderrahmane Mami Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARZOUK Mahmoud, MD

CONTACT

0021620874718; mahmoudmarzouk@hotmail.fr

OUERGHI Sonia, MD

CONTACT

ouerghisonia09@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor anesthesiology and intensive care

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 26, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)