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CHHIPS(卒中后立即控制高血压和低血压)试点试验:原理与设计

CHHIPS (Controlling Hypertension and Hypotension Immediately Post-Stroke) Pilot Trial: rationale and design.

作者信息

Potter J, Robinson T, Ford G, James M, Jenkins D, Mistri A, Bulpitt C, Drummond A, Jagger C, Knight J, Markus H, Beevers G, Dewey M, Lees K, Moore A, Paul S

机构信息

Department of Cardiovascular Science, Leicester Warwick Medical Schools, University Hospitals of Leicester NHS Trust, The Glenfield Hospital, Leicester, UK.

出版信息

J Hypertens. 2005 Mar;23(3):649-55. doi: 10.1097/01.hjh.0000160224.94220.e7.

DOI:10.1097/01.hjh.0000160224.94220.e7
PMID:15716709
Abstract

RATIONALE

High and low blood pressure (BP) levels are common following acute stroke, with up to 60% of patients being hypertensive (SBP > 160 mmHg) and nearly 20% having relative hypotension (SBP < or = 140 mmHg), within the first few hours of ictus, both conditions being associated with an adverse prognosis. At present, the optimum management of blood pressure in the immediate post-stroke period is unclear.

OBJECTIVE

The primary aim of the Controlling Hypertension and Hypotension Immediately Post-Stroke (CHHIPS) Pilot Trial is to assess whether hypertension and relative hypotension, manipulated therapeutically in the first 24 h following acute stroke, affects short-term outcome measures.

DESIGN

The CHHIPS Pilot Trial is a UK based multi-centre, randomized, double-blind, placebo-controlled, titrated dose trial.

SETTING

Acute stroke and medical units in teaching and district general hospitals, in the UK.

PATIENTS

The CHHIPS Pilot Study aims to recruit 2050 patients, with clinically suspected stroke, confirmed by brain imaging, who have no compelling indication or contraindication for BP manipulation.

STUDY OUTCOMES

The primary outcome measure will be the effects of acute pressor therapy (initiated < or = 12 h from stroke onset) or depressor therapy (started < or = 24 h post-ictus) on death and dependency at 14 days post-stroke. Secondary outcome measures will include the influence of therapy on early neurological deterioration, the effectiveness of treatment in manipulating BP levels, the influence of time to treatment and stroke type on response and a cost-effectiveness analysis.

摘要

理论依据

急性中风后,高血压和低血压情况都很常见,在发病后的最初几个小时内,高达60%的患者血压升高(收缩压>160 mmHg),近20%的患者有相对性低血压(收缩压≤140 mmHg),这两种情况都与不良预后相关。目前,中风后即刻的最佳血压管理尚不清楚。

目的

中风后即刻控制高血压和低血压(CHHIPS)试点试验的主要目的是评估急性中风后24小时内通过治疗手段控制高血压和相对性低血压是否会影响短期预后指标。

设计

CHHIPS试点试验是一项在英国进行的多中心、随机、双盲、安慰剂对照、剂量滴定试验。

地点

英国教学医院和地区综合医院的急性中风及医疗科室。

患者

CHHIPS试点研究旨在招募2050名经脑部影像学确诊为临床疑似中风且无血压控制的明确指征或禁忌证的患者。

研究结果

主要结局指标将是急性升压治疗(中风发作后≤12小时开始)或降压治疗(发病后≤24小时开始)对中风后14天死亡和依赖情况的影响。次要结局指标将包括治疗对早期神经功能恶化的影响、治疗在控制血压水平方面的有效性、治疗时间和中风类型对反应的影响以及成本效益分析。

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