Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by Ivabradine
NCT ID: NCT01186783
Last Updated: 2010-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2010-05-31
2012-05-31
Brief Summary
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Detailed Description
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The investigators hypothesized that critically ill patients could derive particular benefit from the specific HR-lowering agent ivabradine.
Methods: MODIfY is a prospective, single center, open label, randomized, controlled two arms, Phase II-trial to evaluate the ability of ivabradine to reduce an elevated heart rate in MODS patients. The primary end point is the proportion of patients with a reduction of heart rate by at least 10 beats per minute (bpm) within 4 days. This trial will randomize 70 patients (men and women, aged ≥18 years) with newly diagnosed MODS (Acute Physiology and Chronic Health Evaluation (APACHE) II-score ≥20, diagnosis within ≤24 hours), with an elevated heart rate (sinus rhythm with HR ≥90 bpm) and contraindications to BBs. Treatment period will last 4 days. All patients will be followed for up to six months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard treatment
All patients receive established medical therapy according to current guidelines and therapeutic standards.
No interventions assigned to this group
ivabradine (add-on)
Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or percutaneous endoscopic gastrostomy-probe) of ivabradine for 4 days.
ivabradine
Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or percutaneous endoscopic gastrostomy-probe) of ivabradine for 4 days.
Day 1 and 2:
5,0 mg ivabradine b.i.d. if heart rate ≥60bpm (acute renal failure: ≥70bpm)
Day 3 and 4:
5,0 mg ivabradine b.i.d. if 60bpm≥heart rate\<90bpm (acute renal failure: 70bpm≥heart rate \<90bpm
7,5 mg ivabradine b.i.d. if heart rate ≥90bpm
Interventions
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ivabradine
Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or percutaneous endoscopic gastrostomy-probe) of ivabradine for 4 days.
Day 1 and 2:
5,0 mg ivabradine b.i.d. if heart rate ≥60bpm (acute renal failure: ≥70bpm)
Day 3 and 4:
5,0 mg ivabradine b.i.d. if 60bpm≥heart rate\<90bpm (acute renal failure: 70bpm≥heart rate \<90bpm
7,5 mg ivabradine b.i.d. if heart rate ≥90bpm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Multiple organ dysfunction syndrome diagnosed ≤ 24 h
* Sinus rhythm with heart rate ≥ 90bpm
* Existing contraindications to beta-receptor blockade
* Written informed consent or identified or suspected positive will with respect to the trial treatment
Exclusion Criteria
* Pregnancy, lactation
* Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate \<30ml/min
* Patients with malignant hyperthermia
* Burn patients
* Patients with acute rejection after organ transplantation
* Patients with bleedings and need for transfusion
* Resuscitated patients with suspected hypoxic brain injury
* Patients who have participated or participate in other studies within the last 3 months
* Other types of shock than septic or cardiogenic shock
* Patients with severe valvular heart disease
* Hypersensitivity to the active substance or any of the excipients
* Severe hepatic insufficiency
* Sick sinus syndrome
* Sinu-atrial block
* pacemaker-dependency
* 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))
18 Years
ALL
No
Sponsors
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Servier
INDUSTRY
KKS Netzwerk
NETWORK
Martin-Luther-Universität Halle-Wittenberg
OTHER
Responsible Party
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Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
Principal Investigators
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Karl Werdan, MD, Professor
Role: STUDY_CHAIR
Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
Henning Ebelt, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
Sebastian Nuding, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
Locations
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Department of Medicine III of the University Clinics Halle (Saale) of the Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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KKSH-067
Identifier Type: -
Identifier Source: org_study_id