Clinical trial NCT04167644: Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.
Official title: Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra Cerebral Hemorrhage
Hypertension
Keywords: ICH, Hypertension, GCS , and mRS.
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The present study was conducted during the period from May 2018 to the end of April 2019. This study was conducted on150 patients presented by acute spontaneous intracerebral hemorrhage (ICH) were admitted to the Department of Neurology of Mansoura University Hospital. Modified Rankin Scale score (mRS) after discharge was calculated and accordingly, patients were partitioned into two main groups: The first group was favorable outcome patients (mRS queal 0-2) and the second group was unfavorable outcome patients (mRS queal 3-6). Independent factors that were significantly related to prognosis were assessed by multivariate logistic regression.

Brief summary: The ideal management of blood pressure in BP after acute intracerebral haemorrhage is still debated and whether a higher intensive reduction of blood pressure after acute intracerebral haemorrhage may be better or not is still controversial. Conflicting results from different randomized trials in regards to the clinical guidelines for management of hypertension in people with acute intracerebral hemorrhage (ICH). These results indicate that the management of BP and the prognosis after acute spontaneous ICH are very complicated.

Therefore, analysis based on actual blood pressure (BP) accomplished may be a more efficient method to assess the impact of BP management on outcome of ICH.

In our research, blood pressure (BP) management and prognosis were studied in patients with acute intracerebral hemorrhage to decide the perfect time control BP to improve outcome.

Detailed description: Methods:

Patients were diagnosed by clinical examination and according to the initial CT brain after the onset of ICH.

Intensive management of blood pressure (BP) started once the diagnosis of intracerebral hemorrhage was established. Systolic blood pressure targeted 140 mm Hg by IV drug that lower BP like nicardipine or diltiazem. Oral antihypertensive medications like (Angiotensin II Receptor Blockers (ARBs) or Ca-blocker), after 24 h of hospitalization, was utilized in combination and step by step changed from intravenous administration.

Patients were exposed to:

A) Complete history taking and complete clinical assessment including neurological and general examinations.

B) Initial Glasgow Coma Scale score at admission to hospital and patients according to GCS score were classified to 3 groups I (13-15), II (5-12), and III (3-4 ) according to Hemphill et al 2001.

C-Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to six\].

D- Routine laboratory examinations including CBC, blood sugar, coagulation tests, renal and hepatic functions.

E- CT brain was accomplished for all patients at onset of admission to hospital to decide the characters of spontaneous intracerebral hemorrhage (ICH). The volume of the intracerebral hemorrhage was determined utilizing the ABC/2 method (A is the most great diameter on the most large ICH cut, B is the diameter perpendicular to A, while, C is the number of axial cuts of ICH multiplied by the thickness of cuts. Additionally, the location ICH (regardless of whether infra or supatrentorial), and if there is IVH or not, also, if there is shift of midline structure or hydrocephalic changes were determined. Regarding ICH volume, patients were partitioned into two groups (\< 30 cm3 and ≥30 cm3).

Statistical analysis

SPSS version 19.0 was utilized for statistical analysis. Data were collected and displayed as numbers proportions, mean ± standard deviation, and range. Favorable and unfavorable groups were compared by chi-square measurement. For variable with ordinary distributions and homogeneous variances, Student's t-test was utilized to check the significant difference between the mean ± standard deviation values in the two groups. P value \<0.05 were considered of statistical significant results.

Multivariate logistic regression analysis was accomplished for the independent variables or factors that were accompanied by better outcomes: like younger ages, GCS at admission, diastolic blood pressure one hour after admission, systolic BP 6 h after admission, and systolic blood pressure 24 h after admission.

Eligibility criteria: Inclusion Criteria:

- Patients incorporated into this study aged over 25 years of either sex with first spontaneous intracerebral hemorrhage (ICH).

Exclusion Criteria:

* Secondary ICH were excluded from this study (like traumatic, hemorrhagic infarcts, AVM, bleeding tumors or SOL, or IVH only without ICH).
* Patients with previous ischemic stroke or T1As

Primary outcomes:
measure: Glasgow Coma Scale score
timeFrame: 24 hours
measure: CT brain
timeFrame: 24 hours
Secondary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
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