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Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine (REHSI)

Primary Purpose

Sepsis, Severe

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ivabradine Oral Product
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis, Severe focused on measuring ivabradine, sepsis, heart rate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Severe sepsis due to coronary and non-coronary etiology
  2. Severe sepsis diagnosed ≤ 24 h
  3. Sinus rhythm with heart rate ≥ 100bpm
  4. Written informed consent or identified or suspected positive will with respect to the trial treatment

Exclusion Criteria:

  1. Patients who have not yet completed the 18th year of age
  2. Pregnancy, lactation
  3. Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate <30ml/min
  4. severe hepatic insufficiency
  5. Sick sinus syndrome
  6. Sinu-atrial block
  7. pacemaker-dependency 8.3rd degree AV block

9.Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Summary of Product Characteristics (SPC))

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Ivabradine oral product

    control group

    Arm Description

    Patients in the ivabradine treatment arm receive interventions:an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days.

    All patients receive established medical therapy according to current guidelines and therapeutic standards.

    Outcomes

    Primary Outcome Measures

    mean heart rate
    the reduction of the mean heart rate of 24 hours after the start of trial treatment

    Secondary Outcome Measures

    severity of illness
    measured by serial APACHE II score monitoring and Sequential Organ Failure Sequential Organ Failure Assessment (SOFA) score monitoringAssessment (SOFA) score monitoring
    mean heart rate
    comparison of the mean heart rate between the treatment and control group
    mortality
    28-day and 6 months mortality

    Full Information

    First Posted
    October 1, 2017
    Last Updated
    December 4, 2017
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03367026
    Brief Title
    Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine
    Acronym
    REHSI
    Official Title
    Reducing Elevated Heart Rate in Patients With Severe Sepsis by by the "Funny Channel" Current (If) Inhibitor Ivabradine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    REHSI is a prospective, multi-center, open label, randomized, controlled two arms, to evaluate the ability of ivabradine to reduce an elevated heart rate in septic shock patients. The primary end point is the reduction of heart rate within 24 hours. This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed Septic Shock (despite adequate fluid resuscitation, were still requiring high-dose norepinephrine (NE) to maintain a mean arterial pressure (MAP) ≥65 mmHg , and had a tachycardia >100 beats per minute (bpm). Treatment period will last 4 days. All patients will be followed for up to six months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis, Severe
    Keywords
    ivabradine, sepsis, heart rate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ivabradine oral product
    Arm Type
    Active Comparator
    Arm Description
    Patients in the ivabradine treatment arm receive interventions:an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    All patients receive established medical therapy according to current guidelines and therapeutic standards.
    Intervention Type
    Drug
    Intervention Name(s)
    Ivabradine Oral Product
    Other Intervention Name(s)
    routine therapy
    Intervention Description
    Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days. Day 1 : 2.5 mg ivabradine b.i.d. if heart rate ≥90 bpm Day 2,3,4: 2.5 mg ivabradine b.i.d. if 60bpm≥heart rate<90bpm. 5.0mg ivabradine b.i.d. if heart rate ≥90bpm
    Primary Outcome Measure Information:
    Title
    mean heart rate
    Description
    the reduction of the mean heart rate of 24 hours after the start of trial treatment
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    severity of illness
    Description
    measured by serial APACHE II score monitoring and Sequential Organ Failure Sequential Organ Failure Assessment (SOFA) score monitoringAssessment (SOFA) score monitoring
    Time Frame
    4 days
    Title
    mean heart rate
    Description
    comparison of the mean heart rate between the treatment and control group
    Time Frame
    4 days
    Title
    mortality
    Description
    28-day and 6 months mortality
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Severe sepsis due to coronary and non-coronary etiology Severe sepsis diagnosed ≤ 24 h Sinus rhythm with heart rate ≥ 100bpm Written informed consent or identified or suspected positive will with respect to the trial treatment Exclusion Criteria: Patients who have not yet completed the 18th year of age Pregnancy, lactation Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate <30ml/min severe hepatic insufficiency Sick sinus syndrome Sinu-atrial block pacemaker-dependency 8.3rd degree AV block 9.Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Summary of Product Characteristics (SPC))

    12. IPD Sharing Statement

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