Cardiac Output, LowPhase 3AMORINCT00446017
The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG
A Phase 3 study testing adrenaline and milrinone in people with Cardiac Output, Low, run by University of Luebeck.
Trial summary
Myocardial dysfunction necessitating inotropic support is a typical complication after on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support after coronary-artery-bypass-grafting. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Output, Low
- What is being tested?
- adrenaline and milrinone
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Apr 2007
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiac index below 2.2 l/min/m2 upon intensive care unit admission despite optimized filling pressures and normalized mean arterial blood pressure (MAP) after elective coronary artery bypass grafting
Who cannot join
- intraoperative use of diuretics or hydroxyethylstarch
About this study
Official title: Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction
Myocardial dysfunction necessitating inotropic support is a typical complication after on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support after coronary-artery-bypass-grafting. With respect to data derived from patients with sepsis shock and results from studies using phosphodiesterase-inhibitors prophylactically, the hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects (hyperlactatemia and hyperglycemia) and renal dysfunction.
Read the detailed description
Following preoperative written informed consent, patients presenting with a cardiac-index (CI) < 2.2 l/min/m2 upon ICU-admission - despite adequate mean arterial (titrated with noradrenaline or sodium-nitroprusside) and filling pressures - will be randomized to 14 hour treatment with adrenaline or milrinone to achieve a CI > 3.0 l/min/m2.
A group of patients not needing inotropes will be used as controls. Hemodynamics, metabolism (plasma lactate, pyruvate, glucose, acid-base status, insulin requirements) and renal function (urinary excretion of alpha-1-microglobulin, creatinine clearance, plasma cystatin-C levels) will be determined during the treatment period and up to 48 hours after surgery (follow up period).
The study is designed as a pilot study including 20 patients per group.
- Conditions
- Cardiac Output, Low
- Being tested
- adrenaline, milrinone
- Keywords
- coronary artery bypass grafting, inotropes, metabolism, renal failure
- Medical subject headings
- Cardiac Output, Low, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenalineDrug
milrinoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lactate concentration in the immediate postoperative period
Secondary outcomes (6)
Hemodynamics
Plasma pyruvate
Plasma glucose
Plasma creatinine
Urinary excretion of alpha-1-microglobulin
Plasma cystatin C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startJun 2003
- Primary completionAug 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Investigators
- Matthias Heringlake, MD, Principal investigator, Department of Anesthesiology, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446017
- Sponsor's protocol ID
- HL-ANAE-101
- Acronym
- AMORI
- Status last verified
- Apr 2007
- First submitted
- 9 Mar 2007
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heringlake M, Wernerus M, Grunefeld J, Klaus S, Heinze H, Bechtel M, Bahlmann L, Poeling J, Schon J. The metabolic and renal effects of adrenaline and milrinone in patients with myocardial dysfunction after coronary artery bypass grafting. Crit Care. 2007;11(2):R51. doi: 10.1186/cc5904.
PubMed 17470271
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction
- ClinicalTrials.gov ID
- NCT00446017
- Acronym / sponsor ID
- AMORI / HL-ANAE-101
- Conditions
- Cardiac Output, Low
- Keywords
- coronary artery bypass grafting, inotropes, metabolism, renal failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Study start
- Jun 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 12 Mar 2007 (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.
Myocardial dysfunction necessitating inotropic support is a typical complication after on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support after coronary-artery-bypass-grafting. With respect to data derived from patients with sepsis shock and results from studies using phosphodiesterase-inhibitors prophylactically, the hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects (hyperlactatemia and hyperglycemia) and renal dysfunction.
Detailed description
Following preoperative written informed consent, patients presenting with a cardiac-index (CI) < 2.2 l/min/m2 upon ICU-admission - despite adequate mean arterial (titrated with noradrenaline or sodium-nitroprusside) and filling pressures - will be randomized to 14 hour treatment with adrenaline or milrinone to achieve a CI > 3.0 l/min/m2.
A group of patients not needing inotropes will be used as controls. Hemodynamics, metabolism (plasma lactate, pyruvate, glucose, acid-base status, insulin requirements) and renal function (urinary excretion of alpha-1-microglobulin, creatinine clearance, plasma cystatin-C levels) will be determined during the treatment period and up to 48 hours after surgery (follow up period).
The study is designed as a pilot study including 20 patients per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cardiac index below 2.2 l/min/m2 upon intensive care unit admission despite optimized filling pressures and normalized mean arterial blood pressure (MAP) after elective coronary artery bypass grafting
Key exclusion criteria (1 listed)
- intraoperative use of diuretics or hydroxyethylstarch
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 |
|---|---|---|
| adrenaline | Drug | – |
| milrinone | Drug | – |
Primary outcome
Plasma lactate concentration in the immediate postoperative period
6 secondary outcomes
Hemodynamics
Plasma pyruvate
Plasma glucose
Plasma creatinine
Urinary excretion of alpha-1-microglobulin
Plasma cystatin C
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 17470271Heringlake M, Wernerus M, Grunefeld J, Klaus S, Heinze H, Bechtel M, Bahlmann L, Poeling J, Schon J. The metabolic and renal effects of adrenaline and milrinone in patients with myocardial dysfunction after coronary artery bypass grafting. Crit Care. 2007;11(2):R51. doi: 10.1186/cc5904.
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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.
Matthias Heringlake, MD principal investigator
Department of Anesthesiology, University of Luebeck
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adrenaline and milrinone in people with Cardiac Output, Low, run by University of Luebeck.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lactate concentration in the immediate postoperative period. 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 NCT00446017, which also lists 1 linked publication.
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 3 Jun 2015.