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The relative increase in the mPAP with the same unit increase in MAP adjusted for baseline, and RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery.
The specific aims of our study are to compare 1) the relative increase in the mPAP with the same unit increase in MAP adjusted for baseline and 2) RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery. We hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support. Second, we will test the hypothesis that vasopressin is associated with improved right ventricular global longitudinal strain compared to norepinephrine in patients requiring vasopressor support during cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| use of vasopressin | Active Comparator | Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients |
|
| use of norepinephrine | Active Comparator | Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin | Drug | Vasopressin (20 IU/100 ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps |
| Measure | Description | Time Frame |
|---|---|---|
| mPAP-to-MAP Ratio | The intraoperative mean pulmonary artery pressure(mPAP) adjusted for systemic mean arterial pressure(MAP), using a time-weighted average mPAP-to-MAP ratio measured during 20 minute period after chest closure | during 20 minute period after chest closure |
| Measure | Description | Time Frame |
|---|---|---|
| RV Free Wall Strain | Right Ventricular Free Wall Longitudinal Strain (RV FWLS) is a measure of the deformation (strain) of the right ventricle's free wall (the part not attached to the septum) during contraction. It quantifies how much the myocardium in the free wall of the right ventricle shortens along its longitudinal axis (base to apex) during systole (contraction). It is expressed as a negative percentage (%), where more negative values indicate better contractility (e.g., -20% is better than -10%). In this study, it was measured by transesophageal echocardiography in the 2D mid-esophageal four-chamber view during a steady state period after chest closure |
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Inclusion criteria:
Adults> 18 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariya Geube, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
This is a unblinded alternating trial. The treatment will be randomized in one week blocks and not by patient, using the RedCap system. This means that during any week, eligible patients will be exposed to the same vasopressor agent (vasopressin or norepinephrine). And the following week there will be new randomization in place. Allocations will be directly communicated to anesthesia personnel and by signs prominently displayed in anesthesia ready room.
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| ID | Title | Description |
|---|---|---|
| FG000 | The Use of Vasopressin | This group including patients who received vasopressin on the pulmonary circulation in cardiac surgery. |
| FG001 | The Use of Norepinephrine | This group including patients who received norepinephrine on the pulmonary circulation in cardiac surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In the final study population, 153 patients were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Using Intraoperative Vasopressin | Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients |
| BG001 | Patients Using Intraoperative Norepinephrine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | mPAP-to-MAP Ratio | The intraoperative mean pulmonary artery pressure(mPAP) adjusted for systemic mean arterial pressure(MAP), using a time-weighted average mPAP-to-MAP ratio measured during 20 minute period after chest closure | Not all the patients in the 2 groups with preoperative pulmonary arterial hypertension, we only included the eligible patients. | Posted | Mean | Standard Deviation | ratio of mPAP-to-MAP | during 20 minute period after chest closure |
|
Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Use of Vasopressin | Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients |
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Our study protocol excluded patients at particularly high risk for acute right ventricular failure. Thus, our conclusions should not be extrapolated to such vulnerable populations. Our analysis was not adequately powered to evaluate mortality and other major clinical outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mariya Geube | Cleveland Clinic Foundation | 216-444-2779 | Geubem@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2024 | Oct 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2024 | Oct 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Randomized cluster crossover study
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| Norepinephrine | Drug | Norepinephrine (4 mg/250ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps |
|
| during 20 minutes period after chest closure |
Hemodynamic effect of Norepinephrine on the pulmonary circulation in cardiac surgery patients
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Comorbid conditions | Count of Participants | Participants |
|
| Preoperative RV dysfunction | Right Ventricular (RV) Dysfunction refers to the impaired function of the right ventricle of the heart, which is responsible for pumping deoxygenated blood from the body into the lungs for oxygenation. RV dysfunction can lead to inadequate blood flow to the lungs and subsequent systemic complications. | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
| Primary or repeat surgery | Count of Participants | Participants |
|
| The Use of Norepinephrine |
Norepinephrine (4 mg/250ml in 5% dextrose) was stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients |
|
|
|
| Secondary | RV Free Wall Strain | Right Ventricular Free Wall Longitudinal Strain (RV FWLS) is a measure of the deformation (strain) of the right ventricle's free wall (the part not attached to the septum) during contraction. It quantifies how much the myocardium in the free wall of the right ventricle shortens along its longitudinal axis (base to apex) during systole (contraction). It is expressed as a negative percentage (%), where more negative values indicate better contractility (e.g., -20% is better than -10%). In this study, it was measured by transesophageal echocardiography in the 2D mid-esophageal four-chamber view during a steady state period after chest closure | Included all patients for RV free wall strain. As not all the patients with/without preoperative pulmonary arterial hypertension, so the study pop in subgroup are different. | Posted | Mean | Standard Deviation | percentage of RV free wall strain | during 20 minutes period after chest closure |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | The Use of Norepinephrine | Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| RV free wall strain with preop pulmonary hypertension |
|
|
| RV free wall strain without preop pulmonary hypertension |
|
|
| RV free wall strain compare between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP < 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension; | Mixed Models Analysis | 0.39 | Mean Difference (Final Values) | -2.1 | 2-Sided | 95 | -7.1 | 2.8 | Equivalence | We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by considering patients who have preoperative pulmonary hypertension. The number of patients in norepinephrine group is 34 and in vasopressin group is 28. The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was < 0.10. |
| We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by separately considering patients who did not have preoperative pulmonary hypertension. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP < 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension. | Mixed Models Analysis | 0.63 | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -7.6 | 4.6 | Equivalence | We're going to explore the interaction between preoperative pulmonary arterial hypertension status and treatment group by equivalence analysis. The number of patients in norepinephrine group is 22 and in vasopressin group is 18.The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was < 0.10. |