Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine

Sepsis, Severe Clinical Trial

— REHSI  

Official title:

Reducing Elevated Heart Rate in Patients With Severe Sepsis by by the "Funny Channel" Current (If) Inhibitor Ivabradine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03367026
• Other study ID #: REHSI
• Status: Not yet recruiting
• Phase: N/A
• First received: October 1, 2017
• Last updated: December 4, 2017
• Start date: January 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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))

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Severe
• Toxemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean heart rate	the reduction of the mean heart rate of 24 hours after the start of trial treatment	24 hours
Secondary	severity of illness	measured by serial APACHE II score monitoring and Sequential Organ Failure Sequential Organ Failure Assessment (SOFA) score monitoringAssessment (SOFA) score monitoring	4 days
Secondary	mean heart rate	comparison of the mean heart rate between the treatment and control group	4 days
Secondary	mortality	28-day and 6 months mortality	6 months