Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine

NCT ID: NCT03367026

Last Updated: 2017-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-06-30

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.

Conditions

Sepsis, Severe

Keywords

ivabradine; sepsis; heart rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ivabradine Oral Product

Intervention Type: DRUG

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

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

routine therapy

Eligibility 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))

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

REHSI

Identifier Type: -

Identifier Source: org_study_id