Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage

Salil Gupta, A. K. Abbot, R. Srinath, A. K. Tewari, Aditya Gupta, S. P. Gorthi, C. S. Narayanan, S. I. Totlani, Y. S. Sirohi, Ravi Anadure

Research output: Contribution to journalArticle

Abstract

Background: Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage. Methods: This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72 h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115 mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130 mm of Hg. The MAP was maintained in the respective arm for another 72 h after which both arms had MAP below 115 mm of Hg. Primary outcome was modified Rankin Scale at 90 days. Results: 118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for “poor outcome” (mRS 3–6) in the tight control arm (safety of the intervention) against “good outcome” (mRS 0–2) was not significant (OR 0.70 [95% CI 0.34–1.47] p = 0.35). Efficacy of the intervention in the form of Odds Ratio for “good outcome” in the tight control arm was not significant (OR 1.43 [95% CI 0.68–2.99], p = 0.35). Conclusion: In patients with spontaneous intracerebral haemorrhage who present within 72 h of the onset of symptoms, MAP can be safely lowered if it crosses 115 mm of Hg but it does not improve clinical outcome.

Original languageEnglish
Pages (from-to)120-125
Number of pages6
JournalMedical Journal Armed Forces India
Volume74
Issue number2
DOIs
Publication statusPublished - 01-04-2018

Fingerprint

Cerebral Hemorrhage
Arterial Pressure
Blood Pressure
Safety
Odds Ratio
Hematoma
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Gupta, Salil ; Abbot, A. K. ; Srinath, R. ; Tewari, A. K. ; Gupta, Aditya ; Gorthi, S. P. ; Narayanan, C. S. ; Totlani, S. I. ; Sirohi, Y. S. ; Anadure, Ravi. / Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage. In: Medical Journal Armed Forces India. 2018 ; Vol. 74, No. 2. pp. 120-125.
@article{6a01ba453b8d468fa97be13cf1eaec87,
title = "Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage",
abstract = "Background: Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage. Methods: This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72 h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115 mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130 mm of Hg. The MAP was maintained in the respective arm for another 72 h after which both arms had MAP below 115 mm of Hg. Primary outcome was modified Rankin Scale at 90 days. Results: 118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for “poor outcome” (mRS 3–6) in the tight control arm (safety of the intervention) against “good outcome” (mRS 0–2) was not significant (OR 0.70 [95{\%} CI 0.34–1.47] p = 0.35). Efficacy of the intervention in the form of Odds Ratio for “good outcome” in the tight control arm was not significant (OR 1.43 [95{\%} CI 0.68–2.99], p = 0.35). Conclusion: In patients with spontaneous intracerebral haemorrhage who present within 72 h of the onset of symptoms, MAP can be safely lowered if it crosses 115 mm of Hg but it does not improve clinical outcome.",
author = "Salil Gupta and Abbot, {A. K.} and R. Srinath and Tewari, {A. K.} and Aditya Gupta and Gorthi, {S. P.} and Narayanan, {C. S.} and Totlani, {S. I.} and Sirohi, {Y. S.} and Ravi Anadure",
year = "2018",
month = "4",
day = "1",
doi = "10.1016/j.mjafi.2017.03.010",
language = "English",
volume = "74",
pages = "120--125",
journal = "Medical Journal Armed Forces India",
issn = "0377-1237",
publisher = "Medical Journal Armed Forces India",
number = "2",

}

Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage. / Gupta, Salil; Abbot, A. K.; Srinath, R.; Tewari, A. K.; Gupta, Aditya; Gorthi, S. P.; Narayanan, C. S.; Totlani, S. I.; Sirohi, Y. S.; Anadure, Ravi.

In: Medical Journal Armed Forces India, Vol. 74, No. 2, 01.04.2018, p. 120-125.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage

AU - Gupta, Salil

AU - Abbot, A. K.

AU - Srinath, R.

AU - Tewari, A. K.

AU - Gupta, Aditya

AU - Gorthi, S. P.

AU - Narayanan, C. S.

AU - Totlani, S. I.

AU - Sirohi, Y. S.

AU - Anadure, Ravi

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Background: Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage. Methods: This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72 h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115 mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130 mm of Hg. The MAP was maintained in the respective arm for another 72 h after which both arms had MAP below 115 mm of Hg. Primary outcome was modified Rankin Scale at 90 days. Results: 118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for “poor outcome” (mRS 3–6) in the tight control arm (safety of the intervention) against “good outcome” (mRS 0–2) was not significant (OR 0.70 [95% CI 0.34–1.47] p = 0.35). Efficacy of the intervention in the form of Odds Ratio for “good outcome” in the tight control arm was not significant (OR 1.43 [95% CI 0.68–2.99], p = 0.35). Conclusion: In patients with spontaneous intracerebral haemorrhage who present within 72 h of the onset of symptoms, MAP can be safely lowered if it crosses 115 mm of Hg but it does not improve clinical outcome.

AB - Background: Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage. Methods: This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72 h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115 mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130 mm of Hg. The MAP was maintained in the respective arm for another 72 h after which both arms had MAP below 115 mm of Hg. Primary outcome was modified Rankin Scale at 90 days. Results: 118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for “poor outcome” (mRS 3–6) in the tight control arm (safety of the intervention) against “good outcome” (mRS 0–2) was not significant (OR 0.70 [95% CI 0.34–1.47] p = 0.35). Efficacy of the intervention in the form of Odds Ratio for “good outcome” in the tight control arm was not significant (OR 1.43 [95% CI 0.68–2.99], p = 0.35). Conclusion: In patients with spontaneous intracerebral haemorrhage who present within 72 h of the onset of symptoms, MAP can be safely lowered if it crosses 115 mm of Hg but it does not improve clinical outcome.

UR - http://www.scopus.com/inward/record.url?scp=85044790776&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85044790776&partnerID=8YFLogxK

U2 - 10.1016/j.mjafi.2017.03.010

DO - 10.1016/j.mjafi.2017.03.010

M3 - Article

VL - 74

SP - 120

EP - 125

JO - Medical Journal Armed Forces India

JF - Medical Journal Armed Forces India

SN - 0377-1237

IS - 2

ER -