Aarhus University Hospital
Aarhus, 8200, Denmark
Location status: Recruiting
NCT Number: NCT07044232
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.
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Request Info18 year and older
All sexes
Interventional
Phase 4
Aarhus, 8200, Denmark
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nicardipine infusion based acute blood pressure lowering treatment
Other names: Labetalol, Methyldopa
Glyceryltrinitrate based acute blood pressure lowering treatment
Other names: Labetalol, Nimotop
Time frame: 1 hour after stroke center admission
Proportion of patients reaching systolic BP <140 mmHg within 1 hour of stroke center admission
Time frame: 90 days (+/- 14 days)
Proportion of patients with acceptable functional outcome at 3 months Defined as modified Rankin Scale (mRS) ≤ 3
Time frame: 0 to 180 days
Use of acute stroke unit bed-days
Time frame: 0 to 180 days
Use of total unit bed-days (Stroke ward and in-hospital rehabilitation)
Time frame: 90 days
Proportion of patients with at least one serious adverse events (SAEs)
Time frame: 0 to 90 days
Proportion of patients experiencing hypotension (systolic blood rpessure <90mmHg or diastolic below 60 mmHg) during the stroke center admission
Time frame: 0 to 90 days
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)
Time frame: 0 to 90 days
Reduced level of consciousness measured as a drop of at least 2 points on the Glascow Coma Scale (range 3-15)
Time frame: 0 to 90 days
Proportion of patients admitted to the intensive carte unit
Time frame: 0 to 90 days
Incidence of surgical intervention (hematoma evacuation or external ventricular drainage) during hospital stay
Time frame: 90 days (+/- 14 days)
All cause mortality at 90 days
Time frame: 180 days (+/- 14 days)
All cause mortality at 180 days
Time frame: 1 hour
Difference in systolic bloodpressure at 1 hour, mmhg
Time frame: 2 hour
Difference in systolic bloodpressure at 2 hour, mmhg
Time frame: 6 hour
Difference in systolic bloodpressure at 6 hour, mmhg
Time frame: From 0 to 72 hours
Nursing time per patient related to acute blood pressure management ( Estimated via time registration in sample patients, 3-5 in each group)
Contact information is provided by the study sponsor or research team.
Claus Z Simonsen, MD, PhD
CONTACT
Rolf Blauenfeldt, MD, PhD
CONTACT
Aarhus University Hospital
Other
NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.
Acronym: NICFAST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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