Status:
UNKNOWN
Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by Ivabradine
Lead Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Collaborating Sponsors:
Servier
KKS Netzwerk
Conditions:
Multiple Organ Dysfunction Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Multiple Organ Dysfunction...
Detailed Description
Background: Heart rate (HR) is of relevant prognostic value not only in the general population and patients with cardiovascular disease but also in critically ill patients with multiple organ dysfunct...
Eligibility Criteria
Inclusion
- Multiple organ dysfunction syndrome (APACHE II score ≥ 20) due to coronary and non-coronary etiology
- 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
- 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
- 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))
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01186783
Start Date
May 1 2010
End Date
May 1 2012
Last Update
September 8 2010
Active Locations (1)
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1
Department of Medicine III of the University Clinics Halle (Saale) of the Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, Germany, 06120