Multiple Organ Dysfunction SyndromePhase 2MODIfYNCT01186783
Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by Ivabradine
A Phase 2 study testing ivabradine in people with Multiple Organ Dysfunction Syndrome, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial 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 Syndrome (MODS) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Organ Dysfunction Syndrome
- What is being tested?
- ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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))
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine III of the University Clinics Halle (Saale) of the Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, 06120
Karl Werdan, MD, Professor, 0049 345 557 ext. 2601, karl.werdan@medizin.uni-halle.de
About this study
Official title: Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by the "Funny Channel" Current (If) Inhibitor Ivabradine
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 Syndrome (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 beta-blockers (BBs). Treatment period will last 4 days. All patients will be followed for up to six months.
Read the 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 dysfunction syndrome (MODS). A raised heart rate in MODS patients is associated with a worse prognosis. Beta-blocker (BB) administration showed to improve autonomic function and exhibited a significantly reduced mortality in MODS. In most cases negative inotropic effects prevent administration of BB in MODS patients which often are treated with catecholamines. In this trial we investigate, whether the "funny current" (If) inhibitor ivabradine is able to reduce pathologically elevated heart rate in MODS- patients.
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
- Multiple Organ Dysfunction Syndrome
- Being tested
- ivabradine
- Keywords
- heart rate, multiple organ dysfunction syndrome, ivabradine, sepsis, cardiogenic shock
- Medical subject headings
- Multiple Organ Failure, Sepsis, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivabradineDrug
Also called Procoralan
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
| Study group | Role | What they receive |
|---|---|---|
| standard treatment | No intervention | All patients receive established medical therapy according to current guidelines and therapeutic standards. |
| ivabradine (add-on) | Active comparator | 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. Receives: Drug: ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean heart rate
percenage of patients with a reduction of the mean heart rate of at least 10 bpm 96 hours after the start of trial treatment
Measured: 4 days
Secondary outcomes (13)
morbidity
group-differences and patient-related changes of morbidity measured by serial APACHE II score monitoring and Sequential Organ Failure Assessment (SOFA) score monitoring
Measured: 4 days
hemodynamic parameters
group-differences and patient-related changes of hemodynamic parameters (cardiac index and cardiac power index) as a consequence of ivabradine treatment
Measured: 4 days
catecholamine dosage
required catecholamine dosage measured by a vasopressor score
Measured: 4 days
microcirculation
improvement of microcirculation as measured by sublingual capillary density and flow
Measured: 4 days
endothelial function
improvement of endothelial function as measured by the "Reactive hyperemia peripheral arterial tonometry-index"
Measured: 4 days
mean heart rate
comparison of the mean heart rate between the treatment and control group after 24 and 48 hours
Measured: 48 hours
mortality
28-day and 6 months mortality
Measured: 6 months
cardiac autonomic dysfunction
impact on cardiac autonomic dysfunction (heart rate variability quantified by time domain measurements (standard deviation of normal to normal interval (SDNN)) and frequency domain measurements (very low frequency (VLF)-, high frequency (HF)- and low frequency (LF)-power) as well as minimum, maximum, day and night heart rate)
Measured: 4 days
number of participants with adverse events as a measure of safety and tolerability
Measured: 6 months
plasma levels of ivabradine in patients with MODS
daily measurement of plasma levels during the treatment period (4 days)
Measured: 4 days
Differences of mortality in different age groups and MODS groups
age sub-groups:
- patients <70 years on day of inclusion
- patients ≥70 years on day of inclusion
MODS sub-groups:
- patients with cardiogenic MODS
- patients with septic MODS
Measured: 6 months
Differences of adverse events in different age groups and MODS groups
age sub-groups:
- patients <70 years on day of inclusion
- patients ≥70 years on day of inclusion
MODS sub-groups:
- patients with cardiogenic MODS
- patients with septic MODS
Measured: 6 months
Differences of heart rate in different age groups and MODS groups
age sub-groups:
- patients <70 years on day of inclusion
- patients ≥70 years on day of inclusion
MODS sub-groups:
- patients with cardiogenic MODS
- patients with septic MODS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Multiple Organ Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Servier, KKS Netzwerk
- Investigators
- Karl Werdan, MD, Professor, Study chair, Medical Faculty of the Martin-Luther-University Halle-Wittenberg, GermanyHenning Ebelt, MD, Principal investigator, Medical Faculty of the Martin-Luther-University Halle-Wittenberg, GermanySebastian Nuding, MD, Principal investigator, Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186783
- Sponsor's protocol ID
- KKSH-067
- Acronym
- MODIfY
- Status last verified
- Sep 2010
- First submitted
- 17 Aug 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Borer JS. Drug insight: If inhibitors as specific heart-rate-reducing agents. Nat Clin Pract Cardiovasc Med. 2004 Dec;1(2):103-9. doi: 10.1038/ncpcardio0052.
PubMed 16265314American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74.
PubMed 1597042Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 Mar 8;344(10):699-709. doi: 10.1056/NEJM200103083441001.
PubMed 11236773Bernardin G, Strosberg AD, Bernard A, Mattei M, Marullo S. Beta-adrenergic receptor-dependent and -independent stimulation of adenylate cyclase is impaired during severe sepsis in humans. Intensive Care Med. 1998 Dec;24(12):1315-22. doi: 10.1007/s001340050768.
PubMed 9885886Cooney MT, Vartiainen E, Laatikainen T, Juolevi A, Dudina A, Graham IM. Elevated resting heart rate is an independent risk factor for cardiovascular disease in healthy men and women. Am Heart J. 2010 Apr;159(4):612-619.e3. doi: 10.1016/j.ahj.2009.12.029.
PubMed 20362720Cucherat M. Quantitative relationship between resting heart rate reduction and magnitude of clinical benefits in post-myocardial infarction: a meta-regression of randomized clinical trials. Eur Heart J. 2007 Dec;28(24):3012-9. doi: 10.1093/eurheartj/ehm489. Epub 2007 Nov 2.
PubMed 17981830Heidland UE, Strauer BE. Left ventricular muscle mass and elevated heart rate are associated with coronary plaque disruption. Circulation. 2001 Sep 25;104(13):1477-82. doi: 10.1161/hc3801.096325.
PubMed 11571239Hennen R, Friedrich I, Hoyer D, Nuding S, Rauchhaus M, Schulze M, Schlisske S, Schwesig R, Schlitt A, Buerke M, Muller-Werdan U, Werdan K, Schmidt H. [Autonomic dysfunction and beta-adrenergic blockers in multiple organ dysfunction syndrome]. Dtsch Med Wochenschr. 2008 Nov;133(48):2500-4. doi: 10.1055/s-0028-1100944. Epub 2008 Nov 19. German.
PubMed 19021079Herndon DN, Barrow RE, Rutan TC, Minifee P, Jahoor F, Wolfe RR. Effect of propranolol administration on hemodynamic and metabolic responses of burned pediatric patients. Ann Surg. 1988 Oct;208(4):484-92. doi: 10.1097/00000658-198810000-00010.
PubMed 3052328Herndon DN, Hart DW, Wolf SE, Chinkes DL, Wolfe RR. Reversal of catabolism by beta-blockade after severe burns. N Engl J Med. 2001 Oct 25;345(17):1223-9. doi: 10.1056/NEJMoa010342.
PubMed 11680441Kjekshus J. Heart rate reduction--a mechanism of benefit? Eur Heart J. 1987 Dec;8 Suppl L:115-22. doi: 10.1093/eurheartj/8.suppl_l.115. No abstract available.
PubMed 2897914Kjekshus JK. Importance of heart rate in determining beta-blocker efficacy in acute and long-term acute myocardial infarction intervention trials. Am J Cardiol. 1986 Apr 25;57(12):43F-49F. doi: 10.1016/0002-9149(86)90888-x.
PubMed 2871745Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003 Apr;29(4):530-8. doi: 10.1007/s00134-003-1662-x. Epub 2003 Mar 28.
PubMed 12664219Manz M, Reuter M, Lauck G, Omran H, Jung W. A single intravenous dose of ivabradine, a novel I(f) inhibitor, lowers heart rate but does not depress left ventricular function in patients with left ventricular dysfunction. Cardiology. 2003;100(3):149-55. doi: 10.1159/000073933.
PubMed 14631136
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by the "Funny Channel" Current (If) Inhibitor Ivabradine
- ClinicalTrials.gov ID
- NCT01186783
- Acronym / sponsor ID
- MODIfY / KKSH-067
- Conditions
- Multiple Organ Dysfunction Syndrome
- Keywords
- heart rate, multiple organ dysfunction syndrome, ivabradine, sepsis, cardiogenic shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Servier, KKS Netzwerk
- Study start
- May 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Syndrome (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 beta-blockers (BBs). Treatment period will last 4 days. All patients will be followed for up to six months.
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 dysfunction syndrome (MODS). A raised heart rate in MODS patients is associated with a worse prognosis. Beta-blocker (BB) administration showed to improve autonomic function and exhibited a significantly reduced mortality in MODS. In most cases negative inotropic effects prevent administration of BB in MODS patients which often are treated with catecholamines. In this trial we investigate, whether the "funny current" (If) inhibitor ivabradine is able to reduce pathologically elevated heart rate in MODS- patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment | No intervention | –All patients receive established medical therapy according to current guidelines and therapeutic standards. |
| ivabradine (add-on) | Active comparator | Drug: ivabradinePatients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or percutaneous endoscopic gastrostomy-probe) of ivabradine for 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ivabradineAlso: ProcoralanPatients 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 | Drug | ivabradine (add-on) |
Primary outcome
mean heart rate
Time frame: 4 days
percenage of patients with a reduction of the mean heart rate of at least 10 bpm 96 hours after the start of trial treatment
13 secondary outcomes
morbidity
Time frame: 4 days
hemodynamic parameters
Time frame: 4 days
catecholamine dosage
Time frame: 4 days
microcirculation
Time frame: 4 days
endothelial function
Time frame: 4 days
mean heart rate
Time frame: 48 hours
mortality
Time frame: 6 months
cardiac autonomic dysfunction
Time frame: 4 days
number of participants with adverse events as a measure of safety and tolerability
Time frame: 6 months
plasma levels of ivabradine in patients with MODS
Time frame: 4 days
Differences of mortality in different age groups and MODS groups
Time frame: 6 months
Differences of adverse events in different age groups and MODS groups
Time frame: 6 months
Differences of heart rate in different age groups and MODS groups
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Background: PubMed 16265314Borer JS. Drug insight: If inhibitors as specific heart-rate-reducing agents. Nat Clin Pract Cardiovasc Med. 2004 Dec;1(2):103-9. doi: 10.1038/ncpcardio0052.
- Background: PubMed 1597042American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74.
- Background: PubMed 11236773Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 Mar 8;344(10):699-709. doi: 10.1056/NEJM200103083441001.
- Background: PubMed 9885886Bernardin G, Strosberg AD, Bernard A, Mattei M, Marullo S. Beta-adrenergic receptor-dependent and -independent stimulation of adenylate cyclase is impaired during severe sepsis in humans. Intensive Care Med. 1998 Dec;24(12):1315-22. doi: 10.1007/s001340050768.
- Background: PubMed 20362720Cooney MT, Vartiainen E, Laatikainen T, Juolevi A, Dudina A, Graham IM. Elevated resting heart rate is an independent risk factor for cardiovascular disease in healthy men and women. Am Heart J. 2010 Apr;159(4):612-619.e3. doi: 10.1016/j.ahj.2009.12.029.
- Background: PubMed 17981830Cucherat M. Quantitative relationship between resting heart rate reduction and magnitude of clinical benefits in post-myocardial infarction: a meta-regression of randomized clinical trials. Eur Heart J. 2007 Dec;28(24):3012-9. doi: 10.1093/eurheartj/ehm489. Epub 2007 Nov 2.
- Background: PubMed 11571239Heidland UE, Strauer BE. Left ventricular muscle mass and elevated heart rate are associated with coronary plaque disruption. Circulation. 2001 Sep 25;104(13):1477-82. doi: 10.1161/hc3801.096325.
- Background: PubMed 19021079Hennen R, Friedrich I, Hoyer D, Nuding S, Rauchhaus M, Schulze M, Schlisske S, Schwesig R, Schlitt A, Buerke M, Muller-Werdan U, Werdan K, Schmidt H. [Autonomic dysfunction and beta-adrenergic blockers in multiple organ dysfunction syndrome]. Dtsch Med Wochenschr. 2008 Nov;133(48):2500-4. doi: 10.1055/s-0028-1100944. Epub 2008 Nov 19. German.
- Background: PubMed 3052328Herndon DN, Barrow RE, Rutan TC, Minifee P, Jahoor F, Wolfe RR. Effect of propranolol administration on hemodynamic and metabolic responses of burned pediatric patients. Ann Surg. 1988 Oct;208(4):484-92. doi: 10.1097/00000658-198810000-00010.
- Background: PubMed 11680441Herndon DN, Hart DW, Wolf SE, Chinkes DL, Wolfe RR. Reversal of catabolism by beta-blockade after severe burns. N Engl J Med. 2001 Oct 25;345(17):1223-9. doi: 10.1056/NEJMoa010342.
- Background: PubMed 2897914Kjekshus J. Heart rate reduction--a mechanism of benefit? Eur Heart J. 1987 Dec;8 Suppl L:115-22. doi: 10.1093/eurheartj/8.suppl_l.115. No abstract available.
- Background: PubMed 2871745Kjekshus JK. Importance of heart rate in determining beta-blocker efficacy in acute and long-term acute myocardial infarction intervention trials. Am J Cardiol. 1986 Apr 25;57(12):43F-49F. doi: 10.1016/0002-9149(86)90888-x.
Related trials for Multiple Organ Dysfunction Syndrome
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
Active, not recruiting
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Multi Organ Failure, Exocrine Pancreatic Insufficiency
Not yet recruitingObservational study
pSOFA Score in Predicting Mortality in Pediatric Intensive Care
Critical Illness, Multiple Organ Dysfunction Syndrome
Not yet recruitingObservational study
Prognostic Value of Stress Hyperglycemia Ratio in Critically Ill Patients
Critical Illness, Hyperglycemia
Not yet recruitingObservational study
FOUR-Based Modification of ICU Severity Scores
ICU Mortality (Survival Rate)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Werdan, MD, Professor study chair
Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
Henning Ebelt, MD principal investigator
Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
Sebastian Nuding, MD principal investigator
Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ivabradine in people with Multiple Organ Dysfunction Syndrome, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Werdan, MD, Professor (0049 345 557 ext. 2601, karl.werdan@medizin.uni-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean heart rate (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186783, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.