<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03800264</url>
  </required_header>
  <id_info>
    <org_study_id>Bisoprolol vs corticosteroi</org_study_id>
    <nct_id>NCT03800264</nct_id>
  </id_info>
  <brief_title>Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery</brief_title>
  <official_title>Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia that occurs after&#xD;
      on pump coronary artery bypass graft (CABG) surgery. It is associated with postoperative&#xD;
      complications, including increased risk of stroke, prolonged hospital stay and increased&#xD;
      costs.&#xD;
&#xD;
      Objectives: The aim of this study was to find reliable, effective, safe and well tolerated&#xD;
      tools for the prevention of AF after on pump coronary artery bypass surgery.&#xD;
&#xD;
      Patients and methods: The study included 176 patients (age range 40 to 79 years) and&#xD;
      scheduled for elective on pump CABG operations without concomitant procedures. The patients&#xD;
      were divided randomly into two equal groups. Group (A) in which bisoprolol was used for&#xD;
      prophylaxis against atrial fibrillation after surgery. Group (B) in which bisoprolol and&#xD;
      hydrocortisone were used for prophylaxis against atrial fibrillation after surgery. For each&#xD;
      patient, the following data were collected: gender, preoperative diseases, intraoperative&#xD;
      cross clamp time, cardiopulmonary bypass time, and Lt internal mammary Artery usage,&#xD;
      incidence of postoperative atrial fibrillation, death, myocardial infarction chest infection&#xD;
      and C - reactive protein levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was conducted at The Cardiothoracic surgery intensive care unit of Ain Shams&#xD;
      University hospitals during a period of 6 months. The study protocol was approved by&#xD;
      &quot;research and ethics committee&quot; of anesthesia and intensive care department, Ain Shams&#xD;
      University. Informative consent was obtained from the patients before enrolling in the study.&#xD;
&#xD;
      176 Patients were registered in the study. Patients were randomly allocated by&#xD;
      computer-generated random number list into two study groups of 88 patients each, with a range&#xD;
      of age between 40 and 79 years old and were undergoing elective on pump CABG operations&#xD;
      without concomitant procedures.&#xD;
&#xD;
      Group A:&#xD;
&#xD;
      Patients received bisoprolol 5mg per oral (P.O.) in the evening of the operation and then one&#xD;
      dose (5 mg) every twenty four hours during the next two days.&#xD;
&#xD;
      Group B:&#xD;
&#xD;
      Patients received bisoprolol as group (A) in addition hydrocortisone 100 mg intravenously is&#xD;
      given in the evening of the operation and then 100 mg every eight hours during the next two&#xD;
      days.&#xD;
&#xD;
      Exclusion criteria for the study included: Patients with preoperative rhythm abnormalities&#xD;
      (sick sinus syndrome, atrioventricular conduction abnormalities, history of chronic or&#xD;
      intermittent AF), pretreatment with classes I and III antiarrhythmic agents, receiving&#xD;
      anti-hypertensive drugs except angiotensin convertor enzyme (ACE) inhibitors, thyroid&#xD;
      disease, renal or liver disease, peripheral arterial atherosclerotic disease,&#xD;
      thrombophlebitis, uncontrolled diabetes mellitus, systemic bacterial or mycotic infection,&#xD;
      active tuberculosis, Cushing's syndrome, peptic ulcer, psychotic mental disorder, Herpes&#xD;
      Simplex keratitis and chronic obstructive pulmonary disease were not included in the study.&#xD;
&#xD;
      Intraoperative technique:&#xD;
&#xD;
      After sedation with diazepam (10 mg intramuscular), radial arterial catheterization,&#xD;
      intravenous catheters, and a central venous catheter were introduced in the operating&#xD;
      theater. Hemodynamic parameters; Heart rate monitoring, mean arterial pressure, rectal&#xD;
      temperature, central venous pressure and arterial blood gas throughout the process was&#xD;
      observed. Anesthesia was started by fentanyl (35 mg / kg) and muscle relaxation was achieved&#xD;
      with pancronium (0.1 mg / kg), then endotracheal intubation using ventilation with 100%&#xD;
      oxygen. The median incision of the sternum was used for cardiac exposure. The left internal&#xD;
      mammary artery was harvested and the saphenous vein was prepared, if necessary. All&#xD;
      operations were performed under cardiopulmonary bypass and moderate hypothermia (28-328C)&#xD;
      with flow rates of 2.2-2.4 l / m2 and the mean perfusion pressure of 50-85 mm Hg. Heart&#xD;
      failure was assisted by initial crystalloid cardioplegia (48C, 15 cc / kg) and heart&#xD;
      preservation was assisted with 400 cc cold blood Cardioplegia every 20 minutes. The hot shut&#xD;
      was performed shortly before removing the cross clamp. The venous cannula was inserted&#xD;
      through the right atrial appendix. The arterial cannula was placed in the ascending aorta.&#xD;
&#xD;
      2.3. Postoperative Monitoring: All patients were continuously monitored at the ICU with&#xD;
      electrocardiography (ECG), invasive blood pressure and with finger probe for oxygen&#xD;
      saturation within 48 h.&#xD;
&#xD;
      Patients developed atrial fibrillation received treatment according to their condition, if&#xD;
      they are haemodynamically unstable electrical cardioversion (synchronized adjusted at 100&#xD;
      joules using biphasic electrical cardiovertor) was applied. If they are haemodynamically&#xD;
      stable pharmacological cardioversion (amiodarone 5 mg/kg intravenous over 60 minutes, then&#xD;
      1.2 grams per day by continuous intravenous infusion) was used. (5)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2018</start_date>
  <completion_date type="Actual">November 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>DOUBLE BLINDED RANDOMIZED STUDY</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>BLINDED</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HEART RATE</measure>
    <time_frame>two days</time_frame>
    <description>atrial fibrillation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Prevention</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>CABG</condition>
  <arm_group>
    <arm_group_label>BISOPROLOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BISOPROLOL 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hydrocortisone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisoprolol</intervention_name>
    <description>PREVENTIVE DOUBLE BLINDED</description>
    <arm_group_label>BISOPROLOL</arm_group_label>
    <arm_group_label>hydrocortisone</arm_group_label>
    <other_name>HYDROCORTISONE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - .176 Patients were registered in the study.&#xD;
&#xD;
        .Range of age between 40 and 79 years old .Undergoing elective on pump CABG operations&#xD;
        without concomitant procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  : Patients with preoperative rhythm abnormalities (sick sinus syndrome,&#xD;
&#xD;
               -  atrioventricular conduction abnormalities,&#xD;
&#xD;
               -  history of chronic or intermittent AF),&#xD;
&#xD;
               -  pretreatment with classes I and III antiarrhythmic agents,&#xD;
&#xD;
               -  receiving anti-hypertensive drugs except angiotensin convertor enzyme (ACE)&#xD;
                  inhibitors,&#xD;
&#xD;
               -  thyroid disease,&#xD;
&#xD;
               -  renal or liver disease,&#xD;
&#xD;
               -  peripheral arterial atherosclerotic disease,&#xD;
&#xD;
               -  thrombophlebitis,&#xD;
&#xD;
               -  uncontrolled diabetes mellitus,&#xD;
&#xD;
               -  systemic bacterial or mycotic infection,&#xD;
&#xD;
               -  active tuberculosis,&#xD;
&#xD;
               -  Cushing's syndrome,&#xD;
&#xD;
               -  peptic ulcer,&#xD;
&#xD;
               -  psychotic mental disorder,&#xD;
&#xD;
               -  Herpes Simplex keratitis&#xD;
&#xD;
               -  chronic obstructive pulmonary disease were not included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ramymahrose</name>
      <address>
        <city>Cairo</city>
        <zip>02</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>RAMY AHMED</investigator_full_name>
    <investigator_title>lecturer</investigator_title>
  </responsible_party>
  <keyword>Bisoprolol,</keyword>
  <keyword>corticosteroid,</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Bisoprolol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800264
org study id: Bisoprolol vs corticosteroi
nct id: NCT03800264
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia that occurs after
      on pump coronary artery bypass graft (CABG) surgery. It is associated with postoperative
      complications, including increased risk of stroke, prolonged hospital stay and increased
      costs.

      Objectives: The aim of this study was to find reliable, effective, safe and well tolerated
      tools for the prevention of AF after on pump coronary artery bypass surgery.

      Patients and methods: The study included 176 patients (age range 40 to 79 years) and
      scheduled for elective on pump CABG operations without concomitant procedures. The patients
      were divided randomly into two equal groups. Group (A) in which bisoprolol was used for
      prophylaxis against atrial fibrillation after surgery. Group (B) in which bisoprolol and
      hydrocortisone were used for prophylaxis against atrial fibrillation after surgery. For each
      patient, the following data were collected: gender, preoperative diseases, intraoperative
      cross clamp time, cardiopulmonary bypass time, and Lt internal mammary Artery usage,
      incidence of postoperative atrial fibrillation, death, myocardial infarction chest infection
      and C - reactive protein levels.
The study was conducted at The Cardiothoracic surgery intensive care unit of Ain Shams
      University hospitals during a period of 6 months. The study protocol was approved by
      "research and ethics committee" of anesthesia and intensive care department, Ain Shams
      University. Informative consent was obtained from the patients before enrolling in the study.

      176 Patients were registered in the study. Patients were randomly allocated by
      computer-generated random number list into two study groups of 88 patients each, with a range
      of age between 40 and 79 years old and were undergoing elective on pump CABG operations
      without concomitant procedures.

      Group A:

      Patients received bisoprolol 5mg per oral (P.O.) in the evening of the operation and then one
      dose (5 mg) every twenty four hours during the next two days.

      Group B:

      Patients received bisoprolol as group (A) in addition hydrocortisone 100 mg intravenously is
      given in the evening of the operation and then 100 mg every eight hours during the next two
      days.

      Exclusion criteria for the study included: Patients with preoperative rhythm abnormalities
      (sick sinus syndrome, atrioventricular conduction abnormalities, history of chronic or
      intermittent AF), pretreatment with classes I and III antiarrhythmic agents, receiving
      anti-hypertensive drugs except angiotensin convertor enzyme (ACE) inhibitors, thyroid
      disease, renal or liver disease, peripheral arterial atherosclerotic disease,
      thrombophlebitis, uncontrolled diabetes mellitus, systemic bacterial or mycotic infection,
      active tuberculosis, Cushing's syndrome, peptic ulcer, psychotic mental disorder, Herpes
      Simplex keratitis and chronic obstructive pulmonary disease were not included in the study.

      Intraoperative technique:

      After sedation with diazepam (10 mg intramuscular), radial arterial catheterization,
      intravenous catheters, and a central venous catheter were introduced in the operating
      theater. Hemodynamic parameters; Heart rate monitoring, mean arterial pressure, rectal
      temperature, central venous pressure and arterial blood gas throughout the process was
      observed. Anesthesia was started by fentanyl (35 mg / kg) and muscle relaxation was achieved
      with pancronium (0.1 mg / kg), then endotracheal intubation using ventilation with 100%
      oxygen. The median incision of the sternum was used for cardiac exposure. The left internal
      mammary artery was harvested and the saphenous vein was prepared, if necessary. All
      operations were performed under cardiopulmonary bypass and moderate hypothermia (28-328C)
      with flow rates of 2.2-2.4 l / m2 and the mean perfusion pressure of 50-85 mm Hg. Heart
      failure was assisted by initial crystalloid cardioplegia (48C, 15 cc / kg) and heart
      preservation was assisted with 400 cc cold blood Cardioplegia every 20 minutes. The hot shut
      was performed shortly before removing the cross clamp. The venous cannula was inserted
      through the right atrial appendix. The arterial cannula was placed in the ascending aorta.

      2.3. Postoperative Monitoring: All patients were continuously monitored at the ICU with
      electrocardiography (ECG), invasive blood pressure and with finger probe for oxygen
      saturation within 48 h.

      Patients developed atrial fibrillation received treatment according to their condition, if
      they are haemodynamically unstable electrical cardioversion (synchronized adjusted at 100
      joules using biphasic electrical cardiovertor) was applied. If they are haemodynamically
      stable pharmacological cardioversion (amiodarone 5 mg/kg intravenous over 60 minutes, then
      1.2 grams per day by continuous intravenous infusion) was used. (5)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: DOUBLE BLINDED RANDOMIZED STUDY
primary purpose: Prevention
masking: Single (Participant)
masking description: BLINDED
measure: HEART RATE
time frame: two days
description: atrial fibrillation
arm group label: BISOPROLOL
arm group type: Active Comparator
description: BISOPROLOL 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days.
arm group label: hydrocortisone
arm group type: Active Comparator
description: hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days.
intervention type: Drug
intervention name: Bisoprolol
description: PREVENTIVE DOUBLE BLINDED
arm group label: BISOPROLOL
arm group label: hydrocortisone
other name: HYDROCORTISONE
criteria: 
gender: All
minimum age: 40 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: RAMY AHMED
investigator title: lecturer
mesh term: Atrial Fibrillation
mesh term: Hydrocortisone
mesh term: Bisoprolol