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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Sepsis, Severe

Treatments: Drug: Ivabradine Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03367026

REHSI

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Ivabradine oral product

Active Comparator group

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.

Treatment:

Drug: Ivabradine Oral Product

control group

No Intervention group

Description:

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