Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine

NCT03367026 | Unknown

• 1 other identifier: REHSI
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• mean heart rate

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

  24 hours

Secondary Outcomes (3)

• severity of illness

  4 days

• mean heart rate

  4 days

• mortality

  6 months

Study Arms (2)

Ivabradine oral product

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

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

Interventions

Ivabradine Oral Product 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

Also known as: routine therapy

Ivabradine oral product

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe sepsis due to coronary and non-coronary etiology
• Severe sepsis diagnosed ≤ 24 h
• Sinus rhythm with heart rate ≥ 100bpm
• Written informed consent or identified or suspected positive will with respect to the trial treatment

You may not qualify if:

• Patients who have not yet completed the 18th year of age
• Pregnancy, lactation
• Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate \<30ml/min
• severe hepatic insufficiency
• Sick sinus syndrome
• Sinu-atrial block
• pacemaker-dependency 8.3rd degree AV block
• 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))

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: December 8, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: December 8, 2017

Record last verified: 2017-10