A Phase 2 interventional study of Hydroxocobalamin and Methylene Blue in Vasoplegia, Hypotension and Coronary Artery Disease, sponsored by Dartmouth-Hitchcock Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by Dartmouth-Hitchcock Medical Center · Phase 2, Interventional, and Treatment
This is a pilot study to determine the hemodynamic effects when hydroxocobalamin vs methylene blue is administered during cardiopulmonary bypass in patients at risk of vasoplegia by measuring mean arterial pressure (MAP), systemic vascular resistance (SVR) and vasopressor requirement.
Type of study: Randomized, placebo-controlled single-center pilot study Expected duration of subject participation: from the start of cardiac surgical procedure to 24 hours after separation from CPB.
Summary description of sequence and duration of all trial periods:
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
Browse Vasoplegia studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
who have 2 or more preoperative risk factors for vasoplegia1-6:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive one intravenous 5-gram dose of hydroxocobalamin reconstituted in 200ml of normal saline over 10-15minutes at the time of initiation of cardiopulmonary bypass.
Drug: Hydroxocobalamin
Participants in this arm will receive one intravenous 2mg/kg dose of methylene blue diluted in 200ml of normal saline over 10-15minutes at the time of initiation of cardiopulmonary bypass.
Drug: Methylene Blue
Participants in this arm will receive an intravenous administration of 200ml normal saline over 10-15minutes at the time of initiation of cardiopulmonary bypass.
Drug: Normal saline
One intravenous dose of 5mg hydroxocobalamin, which is the current FDA-approved adult dose for carbon monoxide poisoning, reconstituted in 200ml normal saline will be administered over 10-15minutes at the time of initiation of cardiopulmonary bypass.
One intravenous dose of methylene blue 2mg/kg, which has been the accepted dose for vasoplegia, diluted in 200ml normal saline will be administered over 10-15minutes at the time of initiation of cardiopulmonary bypass.
200ml normal saline will be administered intravenously over 10-15minutes at the time of initiation of cardiopulmonary bypass.
ΔMAP (baseline to 30 min after CPB separation) in OH-CO and placebo groups.
Our primary outcome measure is the change in MAP between one of the treatment (hydroxocobalamin) and placebo groups measured at 30 minutes post-CPB
Time frame: From baseline to 30 minutes after successful separation from cardiopulmonary bypass (CPB)
ΔMAP (baseline to 30 min after CPB separation) in OH-CO and MB groups.
Our first secondary outcome measure is the change in MAP between the two treatment groups measured at 30 minutes post-CPB
Time frame: From baseline to 30 minutes after successful separation from cardiopulmonary bypass (CPB)
ΔMAP between baseline and all time points (30 and 60 minutes after CPB initiation, and 30 and 60 minutes after CPB separation) between all 3 groups.
Our next secondary outcome measure is the change in MAP between all 3 groups at all measured time points.
Time frame: From baseline to all measured time points (30 and 60 minutes after CPB initiation, and 30 and 60 minutes after CPB separation).
ΔSVR (baseline to 30 min after CPB separation) in OH-CO and placebo groups.
Change in SVR between one of the treatment (hydroxocobalamin) and placebo groups measured at 30 minutes post-CPB
Time frame: From baseline to 30 minutes after successful separation from cardiopulmonary bypass (CPB)
ΔSVR (baseline to 30 min after CPB separation) in OH-CO and MB groups.
Change in SVR between the two treatment groups measured at 30 minutes post-CPB
Time frame: From baseline to 30 minutes after successful separation from cardiopulmonary bypass (CPB)
ΔSVR between baseline and all time points (30 and 60 minutes after CPB initiation, and 30 and 60 minutes after CPB separation) between all 3 groups.
Change in SVR between all 3 groups at all measured time points.
Time frame: From baseline to all measured time points (30 and 60 minutes after CPB initiation, and 30 and 60 minutes after CPB separation).
Differences in phenylephrine requirements during CPB between all 3 groups during CPB
Phenylephrine dose in mcg/kg/min will be recorded from electronic medical record
Time frame: At 30 and 60 minutes after initiation of CPB
Differences in Norepinephrine requirements during CPB between all 3 groups during and after CPB
Norepinephrine dose in mcg/kg/min will be recorded from electronic medical record
Time frame: At 30 and 60 minutes after initiation of CPB, and 30 and 60 minutes after separation from CPB
Differences in Vasopressin requirements during CPB between all 3 groups during and after CPB
Vasopressin dose in units/min will be recorded from electronic medical record
Time frame: At 30 and 60 minutes after initiation of CPB, and 30 and 60 minutes after separation from CPB
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2019; primary completion for May 2020, 6 months later.
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This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Hydroxocobalamin · Methylene Blue
Dartmouth-Hitchcock Medical Center →