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Quality improvement study with a quasi-randomized design. The study monitors the effect of a gradually implemented treatment algorithm prioritizing intravenous antihypertensives (e.g., nicardipine) over long-acting nitrate patches. It aims to increase the proportion of patients reaching target systolic BP <140 mmHg within 1 hour of hospital admission while monitoring safety, clinical outcomes, and healthcare resource utilization.
Spontaneous intracerebral hemorrhage (ICH) is one of the most time-critical neurological emergencies. Rapid lowering of systolic blood pressure to below 140 mmHg (but not below 110 mmHg) has been associated with reduced risk of hematoma expansion and improved long-term functional outcomes. International guidelines recommend that the target blood pressure be achieved within 1 hour of hospital admission.
Traditionally, the specific class of antihypertensive agent used for acute blood pressure management in ICH was considered less important than achieving the target level. However, emerging evidence from two randomized clinical trials has raised concerns regarding the safety of transdermal long-acting nitrate patches (such as glyceryl trinitrate) in the hyperacute phase of stroke. These studies reported signals suggesting potential harm when nitrate patches were used in the early hours after symptom onset. Further, the time from derug administration to blood-pressure control is longer than intravenous administration.
In contrast, intravenous calcium channel blockers such as nicardipine have demonstrated both efficacy and safety in achieving rapid blood pressure control in acute ICH. These agents are widely used in clinical practice and are recommended in national and international guidelines.
In our institution, the standard protocol for acute blood pressure management in ICH has historically included transdermal glyceryl trinitrate patches. In light of emerging safety concerns and new recommendations, we aim to gradually implement a revised protocol centered on intravenous nicardipine. The implementation will be conducted in a cluster randomized stepwise fashion and monitored closely for its effects on blood-pressure control, safety, workflow, and resource utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicardipine infusion based acute blood pressure lowering treatment | Experimental |
Acute antihypertensive treatment duration <72 hours |
|
| Glyceryl trinitrate patchbased acute blood pressure lowering treatment | Active Comparator |
Acute antihypertensive treatment duration <72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicardipine | Combination Product | Nicardipine infusion based acute blood pressure lowering treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target blood pressure < 140 mmHg 1 hour after admission. | Proportion of patients reaching systolic BP <140 mmHg within 1 hour of stroke center admission | 1 hour after stroke center admission |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome at 3 months | Proportion of patients with acceptable functional outcome at 3 months Defined as modified Rankin Scale (mRS) ≤ 3 | 90 days (+/- 14 days) |
| Bed day use | Use of acute stroke unit bed-days |
| Measure | Description | Time Frame |
|---|---|---|
| Time consumption associated with blood pressure management | Nursing time per patient related to acute blood pressure management ( Estimated via time registration in sample patients, 3-5 in each group) | From 0 to 72 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rolf Blauenfeldt, MD, PhD | Contact | +4520774053 | rolfblau@rm.dk | |
| Claus Z Simonsen, MD, PhD | Contact | clausimo@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D009529 | Nicardipine |
| D007741 | Labetalol |
| D008750 | Methyldopa |
| D005996 | Nitroglycerin |
| D009553 | Nimodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Prospective, quasi-randomized, implementation and quality improvement trial with stepwise rollout
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Outcome assessors for 90 days modified Rankin Scale
|
| Glyceryl trinitrate | Combination Product | Glyceryltrinitrate based acute blood pressure lowering treatment |
|
|
| 0 to 180 days |
| Total bed day use | Use of total unit bed-days (Stroke ward and in-hospital rehabilitation) | 0 to 180 days |
| Serious adverse events | Proportion of patients with at least one serious adverse events (SAEs) | 90 days |
| Hypotension | Proportion of patients experiencing hypotension (systolic blood rpessure <90mmHg or diastolic below 60 mmHg) during the stroke center admission | 0 to 90 days |
| Acute kidney injury | Proportion of patients experiencing acute kidney injury during the stroke center admission. (Increase in plasma creatinine of more than 26.5 µmol/L within the past 48 hours, or Increase of 50% or more within 7 days from baseline, defined as the patient's habitual creatinine level, or Urine output of less than 0.5 mL/kg/hour over the past 6 hours despite appropriate therapy) | 0 to 90 days |
| Reduced level of consciousness | Reduced level of consciousness measured as a drop of at least 2 points on the Glascow Coma Scale (range 3-15) | 0 to 90 days |
| Intensive care unit | Proportion of patients admitted to the intensive carte unit | 0 to 90 days |
| Neurosurgery | Incidence of surgical intervention (hematoma evacuation or external ventricular drainage) during hospital stay | 0 to 90 days |
| Mortality | All cause mortality at 90 days | 90 days (+/- 14 days) |
| Mortality | All cause mortality at 180 days | 180 days (+/- 14 days) |
| Systolic bloodpressure at 1 hour | Difference in systolic bloodpressure at 1 hour, mmhg | 1 hour |
| Systolic bloodpressure at 2 hour | Difference in systolic bloodpressure at 2 hour, mmhg | 2 hour |
| Systolic bloodpressure at 6 hour | Difference in systolic bloodpressure at 6 hour, mmhg | 6 hour |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D009574 | Nitro Compounds |
| D009539 | Nicotinic Acids |