Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine

Not Applicable

• Conditions: Sepsis, Severe
• Interventions: Drug: Ivabradine Oral Product

• Registration Number: NCT03367026
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-01
• Study First Submitted QC: 2017-12-04
• Last Update Submitted: 2017-12-04
• Study First Posted: 2017-12-08
• Last Update Posted: 2017-12-08
• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivabradine oral product	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
severity of illness	4 days	measured by serial APACHE II score monitoring and Sequential Organ Failure Sequential Organ Failure Assessment (SOFA) score monitoringAssessment (SOFA) score monitoring
mean heart rate	4 days	comparison of the mean heart rate between the treatment and control group
mortality	6 months	28-day and 6 months mortality