Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.

November 29, 2019 updated by: Ahmed Esmael, Mansoura University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unfavorable outcome
80 patients with poor outcome were classified according to mRS score after discharge (mRS range from 3 up to 6).
Diagnostic test: Modified Rankin Scale (mRS)
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
Favorable outcome
70 patients with better outcome were classified according to mRS score after discharge (mRS range from 0 up to 2) .
Diagnostic test: Modified Rankin Scale (mRS)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Coma Scale score
Time Frame: 24 hours
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.
24 hours
CT brain
Time Frame: 24 hours
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)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS)
Time Frame: 24 hours
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 fModified 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 rom zero up to two, while unfavorable outcome ranging for 3 up to six
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 29, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura University Hospital 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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