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

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ClinicalTrials.gov Identifier: NCT03367026
Recruitment Status : Unknown
Verified October 2017 by Peking Union Medical College Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Sepsis, Severe Drug: Ivabradine Oral Product Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Elevated Heart Rate in Patients With Severe Sepsis by by the "Funny Channel" Current (If) Inhibitor Ivabradine
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Ivabradine

Arm Intervention/treatment
Active Comparator: Ivabradine oral product
Patients in the ivabradine treatment arm receive interventions:an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days.
Drug: Ivabradine Oral Product

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

Other Name: routine therapy

No Intervention: control group
All patients receive established medical therapy according to current guidelines and therapeutic standards.



Primary Outcome Measures :
  1. mean heart rate [ Time Frame: 24 hours ]
    the reduction of the mean heart rate of 24 hours after the start of trial treatment


Secondary Outcome Measures :
  1. severity of illness [ Time Frame: 4 days ]
    measured by serial APACHE II score monitoring and Sequential Organ Failure Sequential Organ Failure Assessment (SOFA) score monitoringAssessment (SOFA) score monitoring

  2. mean heart rate [ Time Frame: 4 days ]
    comparison of the mean heart rate between the treatment and control group

  3. mortality [ Time Frame: 6 months ]
    28-day and 6 months mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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))

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03367026    
Other Study ID Numbers: REHSI
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
ivabradine
sepsis
heart rate
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes