Analgesia-first Minimal Sedation for Spontaneous Intracerebral Hemorrhage Early Antihypertensive Treatment

NCT ID: NCT03207100

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2021-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates safety and efficacy of analgesia-first minimal sedation as an early antihypertensive treatment for spontaneous intracerebral hemorrhage. The analgesia-first minimal sedation strategy relies on the remifentanil-mediated alleviation of pain-induced stress response and the antisympathetic activity of dexmedetomidine to restore the elevated blood pressure to normal level in patients with spontaneous intracerebral hemorrhage. This strategy allows rapid stabilization of blood pressure, and its use as a pre-treatment for patients on mechanical ventilation prior to painful procedures reduces blood pressure variability and thereby results in etiologic treatment. It is more effective in blood pressure control than conventional symptomatic antihypertensive treatment, reduces the incidence of early hematoma expansion and improves prognosis, ,lowers healthcare workers workload, increases patient adherence, and improves healthcare worker satisfaction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Spontaneous intracerebral hemorrhage (ICH) is hemorrhage in the brain parenchyma caused by non-traumatic spontaneous rupture of cerebral artery, arteriole, vein and capillary in adults. ICH is a common problem, with subarachnoid hemorrhage. About 90% ICH patients have increased blood pressure (BP) that usually occurs immediately after disease onset. BP elevation in the acute phase of ICH is associated with poor prognosis, and its mechanism of action includes the local increase of initial hemorrhage, early hematoma expansion at hemorrhagic sites, the increased risk of early recurrent hemorrhage, serious cerebral edema, and recurrent stroke, this affects the most within the few hours following the onset of the disease. The current American Heart Association guidelines recommended early antihypertensive treatment and suggested that rapid decrease of BP to 140 mmHg is safe in ICH patients with no obvious antihypertensive contraindications. However, the significant differences between large studies conducted in recent years have led to great controversy on the effect of early antihypertensive treatment in acute ICH and disease prognosis. A meta-analysis of early antihypertensive treatment for ICH showed that differences in early BP control rate and BP increase variability are also the major causes of inconsistency between these studies. There is currently no consensus on the best antihypertensive regimen as it is difficult to reach the optimal BP level timely. Some studies have shown that stress response, pain, ICP increase and pre-onset BP elevation are factors that cause acute BP increase in ICH patients. In particular, restlessness, sleep deprivation, and stress due to intolerable pain can lead to dramatic BP and intracranial pressure (ICP) increases, further lead to secondary intracerebral hematoma expansion and subsequently cause neurologic degeneration and cerebral tissue damage. Therefore, the primary principles of ICH acute BP increase treatment are to keep quiet, restore BP to normal level, stably reduce BP, decrease BP variability, lower the chance of recurrent hemorrhage, and thereby improve long-term prognosis. Traditional antihypertensive treatment can only resolve the issue of BP elevation but not the root cause of disease. Analgesia and sedation is a critical component of and a global consensus in the clinical management of ICH patients. Remifentanil is a fentanyl μ-type opioid receptor agonist with strong and fast-acting analgesic effects, does not induce ICP elevation and can alleviate pain induced by sputum aspiration, body turning and back clapping in severe patients. A randomized trial on patients with craniocerebral injury has indicated that a remifentanil-based sedation strategy can significantly reduce the amount of sedative used and shorten the time of mechanical ventilation without affecting the functional assessment of the nervous system. Dexmedetomidine is an α2-adrenergic agonist that inhibits sympathetic activity by activating the pre-synaptic α2-receptor in the locus coeruleus, which in turn reduces norepinephrine release, that only slightly affects consciousness and breathing and helps patients with craniocerebral injury stay conscious while under sedation, allowing real-time functional assessment of the nervous system. Therefore, the research group developed a treatment strategy in which sufficient analgesia is applied in combination with a minimal sedation program as an effective and safe early an- tihypertensive treatment.We hypothesize that applying sufficient analgesia in combination with a minimal sedation program will involve the use of remifentanil for pain relief and dexmedetomidine for antisympathetic activity to restore elevated BP to normal levels in patients with spontaneous ICH, and we further hypothesize that this strategy will be more effective than conventional symptomatic antihypertensive treatment for controlling BP.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Systolic Blood Pressure Control Rate Hematoma Growth Blood Pressure Variability Healthcare Worker Satisfaction Duration of ICU Treatment and Mechanical Ventilation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Intracerebral hemorrhage Early antihypertensive treatment Analgesia-first Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects are grouped into the analgesia-first minimal sedation group (experimental group) or antihypertensive drug treatment group (control group) using the central randomization system upon enrollment. Antihypertensive intervention is performed on the subjects in accordance to the protocol of each group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
This study uses a single-blinded design in which only the investigators and not the subjects know the method of intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Analgesia-first minimal sedation group

Using analgesia-first minimal sedation strategy to implement antihypertensive therapy.

Group Type EXPERIMENTAL

Analgesia-first minimal sedation

Intervention Type COMBINATION_PRODUCT

Remifentanil will be administered by IV infusion and maintained at a dose of 0.025 μg/kg/min in non-mechanically ventilated patients and a dose of 0.05 μg/kg/min in mechanically ventilated patients. BP will be measured after 10 min of continuous infusion.If systolic BP is still ≥ 140 mmHg, then dexmedetomidine will be applied using an infusion pump at a dose of 0.2 μg/kg/h. BP will be measured again after 15 min of continuous infusion of dexmedetomidine. If systolic BP is still ≥ 140 mmHg, the dose of dexmedetomidine can be increased 0.1 μg/kg/h to the maximum of 0.6 μg/kg/h.If the maximum dose of dexmedetomidine does not lower blood pressure, use routine blood pressure reduction programs in each center to reduce blood pressure to the target range. Mechanically ventilated patients will be given a rapid remifentanil (0.5 μg/kg) infusion to reduce procedure-related pain.

Antihypertensive drug treatment group

Using routine antihypertensive drugs to implement antihypertensive therapy.

Group Type ACTIVE_COMPARATOR

Antihypertensive treatment

Intervention Type COMBINATION_PRODUCT

Routine antihypertensive treatment will be performed in accordance with the protocol of each respective research center. Urapidil, nicardipine, and labetalol will be used in this group. Urapidil will be used as follows: a slow IV injection of 10-15 mg and then IV pumping for maintenance at an initial rate of 2 mg/min, adjusted according to BP to a maximum of 9 mg/min. Nicardipine will be used as follows: IV pumping at 0.5μg/kg/min adjusted according to BP to a maximum of 6μg/kg/min. Labetalol will be used as follows: IV infusion for maintenance at 1-4 mg/min until the aim is reached.The mechanically ventilated patients in the control group will be administered a rapid physiological saline infusion as a controlled pretreatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Analgesia-first minimal sedation

Remifentanil will be administered by IV infusion and maintained at a dose of 0.025 μg/kg/min in non-mechanically ventilated patients and a dose of 0.05 μg/kg/min in mechanically ventilated patients. BP will be measured after 10 min of continuous infusion.If systolic BP is still ≥ 140 mmHg, then dexmedetomidine will be applied using an infusion pump at a dose of 0.2 μg/kg/h. BP will be measured again after 15 min of continuous infusion of dexmedetomidine. If systolic BP is still ≥ 140 mmHg, the dose of dexmedetomidine can be increased 0.1 μg/kg/h to the maximum of 0.6 μg/kg/h.If the maximum dose of dexmedetomidine does not lower blood pressure, use routine blood pressure reduction programs in each center to reduce blood pressure to the target range. Mechanically ventilated patients will be given a rapid remifentanil (0.5 μg/kg) infusion to reduce procedure-related pain.

Intervention Type COMBINATION_PRODUCT

Antihypertensive treatment

Routine antihypertensive treatment will be performed in accordance with the protocol of each respective research center. Urapidil, nicardipine, and labetalol will be used in this group. Urapidil will be used as follows: a slow IV injection of 10-15 mg and then IV pumping for maintenance at an initial rate of 2 mg/min, adjusted according to BP to a maximum of 9 mg/min. Nicardipine will be used as follows: IV pumping at 0.5μg/kg/min adjusted according to BP to a maximum of 6μg/kg/min. Labetalol will be used as follows: IV infusion for maintenance at 1-4 mg/min until the aim is reached.The mechanically ventilated patients in the control group will be administered a rapid physiological saline infusion as a controlled pretreatment.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Definitive diagnosis of ICH-induced acute brain injury by CT;
2. Systolic BP ≥150 mmHg for at least twice;
3. \>18 years old;
4. Feasible for emergency antihypertensive treatment and real-time BP monitoring;
5. Disease onset is within 24h;
6. ICU or stroke unit admission within 24h.

Exclusion Criteria

1. Subject has contraindications for emergency intensified antihypertensive treatment;
2. Intracranial hemorrhage secondary to intracranial tumor, recent trauma, cerebral infarction and thrombolytic therapy;
3. History of ischemic stroke within 30 days before disease onset;
4. Clinical or imaging examination reveals an expected high mortality in subject within the next 24h;
5. Presence of dementia or significant post-stroke disability;
6. Coagulation disorder caused by drugs or hematologic diseases;
7. Allergy to opioids;
8. Interference test result, assessment and follow-up of comorbidity;
9. Presence of sinus arrest, borderline rhythm, grade II and above atrioventricular block and malignant arrhythmia;
10. Individual is pregnant or lactating;
11. Currently participating in other drug studies or clinical trials;
12. Subject or guardian is unwilling to provide his/her informed consent form, or subject is highly unable to persist with the study and follow-up;
13. Subject's participation in the study will increase his/her study-related risk, and other reasons that make the subject unsuitable for the study as determined by the investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Third Military Medical University

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

The Second Hospital University of South China

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Department of Biostatistics, Southern Medical University

UNKNOWN

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of HuNan University of Medicine

UNKNOWN

Sponsor Role collaborator

Guangdong 999 Brain Hospital

OTHER

Sponsor Role collaborator

Maoming People's Hospital

OTHER

Sponsor Role collaborator

The Fifth Affiliated Hospital of Southern Medical University

OTHER

Sponsor Role collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Hong Yang

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hong Yang

Doctor of Medicine (M.D.);Associate Senior Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wen-Jin Chen

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Hong Yang, Dr

Role: STUDY_CHAIR

The Third Affiliated Hospital of Southern Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Site Status

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status

Guangdong 999 Brain Hospital

Guangzhou, Guangdong, China

Site Status

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

The Fifth Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

MaoMing People's Hospital

Maoming, Guangdong, China

Site Status

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status

Zhongshan People's Hospital

Zhongshan, Guangdong, China

Site Status

The Fifth Affiliated Hospital Sun-yet sen University

Zhuhai, Guangdong, China

Site Status

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

The Second Hospital University of South China

Hengyang, Hunan, China

Site Status

The First Affiliated Hospital of HuNan University of Medicine

Huaihua, Hunan, China

Site Status

Qilu Hospital of Shandong University

Qingdao, Shandong, China

Site Status

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

The First Affiliated Hospital of Kuming Medical University

Kunming, Yunnan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany China

References

Explore related publications, articles, or registry entries linked to this study.

Qureshi AI, Tuhrim S, Broderick JP, Batjer HH, Hondo H, Hanley DF. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 May 10;344(19):1450-60. doi: 10.1056/NEJM200105103441907. No abstract available.

Reference Type BACKGROUND
PMID: 11346811 (View on PubMed)

Chen ST, Chen SD, Hsu CY, Hogan EL. Progression of hypertensive intracerebral hemorrhage. Neurology. 1989 Nov;39(11):1509-14. doi: 10.1212/wnl.39.11.1509.

Reference Type BACKGROUND
PMID: 2812332 (View on PubMed)

Broderick JP, Brott TG, Tomsick T, Barsan W, Spilker J. Ultra-early evaluation of intracerebral hemorrhage. J Neurosurg. 1990 Feb;72(2):195-9. doi: 10.3171/jns.1990.72.2.0195.

Reference Type BACKGROUND
PMID: 2295917 (View on PubMed)

Arakawa S, Saku Y, Ibayashi S, Nagao T, Fujishima M. Blood pressure control and recurrence of hypertensive brain hemorrhage. Stroke. 1998 Sep;29(9):1806-9. doi: 10.1161/01.str.29.9.1806.

Reference Type BACKGROUND
PMID: 9731599 (View on PubMed)

van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.

Reference Type BACKGROUND
PMID: 3363593 (View on PubMed)

Koskinen LO, Olivecrona M, Grande PO. Severe traumatic brain injury management and clinical outcome using the Lund concept. Neuroscience. 2014 Dec 26;283:245-55. doi: 10.1016/j.neuroscience.2014.06.039. Epub 2014 Jun 25.

Reference Type BACKGROUND
PMID: 24973658 (View on PubMed)

Stocchetti N, Pagan F, Calappi E, Canavesi K, Beretta L, Citerio G, Cormio M, Colombo A. Inaccurate early assessment of neurological severity in head injury. J Neurotrauma. 2004 Sep;21(9):1131-40. doi: 10.1089/neu.2004.21.1131.

Reference Type BACKGROUND
PMID: 15453984 (View on PubMed)

Oddo M, Crippa IA, Mehta S, Menon D, Payen JF, Taccone FS, Citerio G. Optimizing sedation in patients with acute brain injury. Crit Care. 2016 May 5;20(1):128. doi: 10.1186/s13054-016-1294-5.

Reference Type BACKGROUND
PMID: 27145814 (View on PubMed)

Broderick JP, Brott TG, Duldner JE, Tomsick T, Huster G. Volume of intracerebral hemorrhage. A powerful and easy-to-use predictor of 30-day mortality. Stroke. 1993 Jul;24(7):987-93. doi: 10.1161/01.str.24.7.987.

Reference Type BACKGROUND
PMID: 8322400 (View on PubMed)

Kazui S, Naritomi H, Yamamoto H, Sawada T, Yamaguchi T. Enlargement of spontaneous intracerebral hemorrhage. Incidence and time course. Stroke. 1996 Oct;27(10):1783-7. doi: 10.1161/01.str.27.10.1783.

Reference Type BACKGROUND
PMID: 8841330 (View on PubMed)

Kasner SE. Clinical interpretation and use of stroke scales. Lancet Neurol. 2006 Jul;5(7):603-12. doi: 10.1016/S1474-4422(06)70495-1.

Reference Type BACKGROUND
PMID: 16781990 (View on PubMed)

Teasdale G, Maas A, Lecky F, Manley G, Stocchetti N, Murray G. The Glasgow Coma Scale at 40 years: standing the test of time. Lancet Neurol. 2014 Aug;13(8):844-54. doi: 10.1016/S1474-4422(14)70120-6.

Reference Type BACKGROUND
PMID: 25030516 (View on PubMed)

Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the Intensive Care Unit: executive summary. Am J Health Syst Pharm. 2013 Jan 1;70(1):53-8. doi: 10.1093/ajhp/70.1.53.

Reference Type BACKGROUND
PMID: 23261901 (View on PubMed)

Stalhammar D, Starmark JE, Holmgren E, Eriksson N, Nordstrom CH, Fedders O, Rosander B. Assessment of responsiveness in acute cerebral disorders. A multicentre study on the reaction level scale (RLS 85). Acta Neurochir (Wien). 1988;90(3-4):73-80. doi: 10.1007/BF01560558.

Reference Type BACKGROUND
PMID: 3354366 (View on PubMed)

Pejtersen JH, Kristensen TS, Borg V, Bjorner JB. The second version of the Copenhagen Psychosocial Questionnaire. Scand J Public Health. 2010 Feb;38(3 Suppl):8-24. doi: 10.1177/1403494809349858.

Reference Type BACKGROUND
PMID: 21172767 (View on PubMed)

Wallace JD, Levy LL. Blood pressure after stroke. JAMA. 1981 Nov 13;246(19):2177-80.

Reference Type RESULT
PMID: 7289008 (View on PubMed)

Harper G, Castleden CM, Potter JF. Factors affecting changes in blood pressure after acute stroke. Stroke. 1994 Sep;25(9):1726-9. doi: 10.1161/01.str.25.9.1726.

Reference Type RESULT
PMID: 8073450 (View on PubMed)

Ong TZ, Raymond AA. Risk factors for stroke and predictors of one-month mortality. Singapore Med J. 2002 Oct;43(10):517-21.

Reference Type RESULT
PMID: 12587706 (View on PubMed)

Becker KJ, Baxter AB, Bybee HM, Tirschwell DL, Abouelsaad T, Cohen WA. Extravasation of radiographic contrast is an independent predictor of death in primary intracerebral hemorrhage. Stroke. 1999 Oct;30(10):2025-32. doi: 10.1161/01.str.30.10.2025.

Reference Type RESULT
PMID: 10512902 (View on PubMed)

Mayer SA, Sacco RL, Shi T, Mohr JP. Neurologic deterioration in noncomatose patients with supratentorial intracerebral hemorrhage. Neurology. 1994 Aug;44(8):1379-84. doi: 10.1212/wnl.44.8.1379.

Reference Type RESULT
PMID: 8058133 (View on PubMed)

Zhou JF, Wang JY, Luo YE, Chen HH. Influence of hypertension, lipometabolism disorders, obesity and other lifestyles on spontaneous intracerebral hemorrhage. Biomed Environ Sci. 2003 Sep;16(3):295-303.

Reference Type RESULT
PMID: 14631835 (View on PubMed)

Kazui S, Minematsu K, Yamamoto H, Sawada T, Yamaguchi T. Predisposing factors to enlargement of spontaneous intracerebral hematoma. Stroke. 1997 Dec;28(12):2370-5. doi: 10.1161/01.str.28.12.2370.

Reference Type RESULT
PMID: 9412616 (View on PubMed)

Gebel JM Jr, Jauch EC, Brott TG, Khoury J, Sauerbeck L, Salisbury S, Spilker J, Tomsick TA, Duldner J, Broderick JP. Natural history of perihematomal edema in patients with hyperacute spontaneous intracerebral hemorrhage. Stroke. 2002 Nov;33(11):2631-5. doi: 10.1161/01.str.0000035284.12699.84.

Reference Type RESULT
PMID: 12411653 (View on PubMed)

Carhuapoma JR, Hanley DF, Banerjee M, Beauchamp NJ. Brain edema after human cerebral hemorrhage: a magnetic resonance imaging volumetric analysis. J Neurosurg Anesthesiol. 2003 Jul;15(3):230-3. doi: 10.1097/00008506-200307000-00010.

Reference Type RESULT
PMID: 12826970 (View on PubMed)

Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

Reference Type RESULT
PMID: 23713578 (View on PubMed)

Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.

Reference Type RESULT
PMID: 20446945 (View on PubMed)

Qureshi AI, Mohammad YM, Yahia AM, Suarez JI, Siddiqui AM, Kirmani JF, Suri MF, Kolb J, Zaidat OO. A prospective multicenter study to evaluate the feasibility and safety of aggressive antihypertensive treatment in patients with acute intracerebral hemorrhage. J Intensive Care Med. 2005 Jan-Feb;20(1):34-42. doi: 10.1177/0885066604271619.

Reference Type RESULT
PMID: 15665258 (View on PubMed)

Terayama Y, Tanahashi N, Fukuuchi Y, Gotoh F. Prognostic value of admission blood pressure in patients with intracerebral hemorrhage. Keio Cooperative Stroke Study. Stroke. 1997 Jun;28(6):1185-8. doi: 10.1161/01.str.28.6.1185.

Reference Type RESULT
PMID: 9183348 (View on PubMed)

Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.

Reference Type RESULT
PMID: 18396107 (View on PubMed)

Manning L, Hirakawa Y, Arima H, Wang X, Chalmers J, Wang J, Lindley R, Heeley E, Delcourt C, Neal B, Lavados P, Davis SM, Tzourio C, Huang Y, Stapf C, Woodward M, Rothwell PM, Robinson TG, Anderson CS; INTERACT2 investigators. Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial. Lancet Neurol. 2014 Apr;13(4):364-73. doi: 10.1016/S1474-4422(14)70018-3. Epub 2014 Feb 13.

Reference Type RESULT
PMID: 24530176 (View on PubMed)

Kate MP, Hansen MB, Mouridsen K, Ostergaard L, Choi V, Gould BE, McCourt R, Hill MD, Demchuk AM, Coutts SB, Dowlatshahi D, Emery DJ, Buck BH, Butcher KS; ICHADAPT Investigators. Blood pressure reduction does not reduce perihematoma oxygenation: a CT perfusion study. J Cereb Blood Flow Metab. 2014 Jan;34(1):81-6. doi: 10.1038/jcbfm.2013.164. Epub 2013 Sep 18.

Reference Type RESULT
PMID: 24045403 (View on PubMed)

Boulouis G, Morotti A, Goldstein JN, Charidimou A. Intensive blood pressure lowering in patients with acute intracerebral haemorrhage: clinical outcomes and haemorrhage expansion. Systematic review and meta-analysis of randomised trials. J Neurol Neurosurg Psychiatry. 2017 Apr;88(4):339-345. doi: 10.1136/jnnp-2016-315346. Epub 2017 Feb 18.

Reference Type RESULT
PMID: 28214798 (View on PubMed)

Egawa S, Hifumi T, Kawakita K, Okauchi M, Shindo A, Kawanishi M, Tamiya T, Kuroda Y. Impact of neurointensivist-managed intensive care unit implementation on patient outcomes after aneurysmal subarachnoid hemorrhage. J Crit Care. 2016 Apr;32:52-5. doi: 10.1016/j.jcrc.2015.11.008. Epub 2015 Dec 2.

Reference Type RESULT
PMID: 26703419 (View on PubMed)

Rodriguez-Luna D, Pineiro S, Rubiera M, Ribo M, Coscojuela P, Pagola J, Flores A, Muchada M, Ibarra B, Meler P, Sanjuan E, Hernandez-Guillamon M, Alvarez-Sabin J, Montaner J, Molina CA. Impact of blood pressure changes and course on hematoma growth in acute intracerebral hemorrhage. Eur J Neurol. 2013 Sep;20(9):1277-83. doi: 10.1111/ene.12180. Epub 2013 May 5.

Reference Type RESULT
PMID: 23647568 (View on PubMed)

Tanaka E, Koga M, Kobayashi J, Kario K, Kamiyama K, Furui E, Shiokawa Y, Hasegawa Y, Okuda S, Todo K, Kimura K, Okada Y, Okata T, Arihiro S, Sato S, Yamagami H, Nagatsuka K, Minematsu K, Toyoda K. Blood pressure variability on antihypertensive therapy in acute intracerebral hemorrhage: the Stroke Acute Management with Urgent Risk-factor Assessment and Improvement-intracerebral hemorrhage study. Stroke. 2014 Aug;45(8):2275-9. doi: 10.1161/STROKEAHA.114.005420. Epub 2014 Jun 26.

Reference Type RESULT
PMID: 24968929 (View on PubMed)

Li M, Zhang Y, Wu KS, Hu YH. Assessment of the effect of continuous sedation with mechanical ventilation on adrenal insufficiency in patients with traumatic brain injury. J Investig Med. 2016 Mar;64(3):752-8. doi: 10.1136/jim-2015-000012. Epub 2016 Feb 10.

Reference Type RESULT
PMID: 26912007 (View on PubMed)

Balestreri M, Czosnyka M, Chatfield DA, Steiner LA, Schmidt EA, Smielewski P, Matta B, Pickard JD. Predictive value of Glasgow Coma Scale after brain trauma: change in trend over the past ten years. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):161-2.

Reference Type RESULT
PMID: 14707332 (View on PubMed)

Engelhard K, Reeker W, Kochs E, Werner C. Effect of remifentanil on intracranial pressure and cerebral blood flow velocity in patients with head trauma. Acta Anaesthesiol Scand. 2004 Apr;48(4):396-9. doi: 10.1111/j.0001-5172.2004.00348.x.

Reference Type RESULT
PMID: 15025597 (View on PubMed)

Yokota H, Yokoyama K, Noguchi H, Nishioka T, Umegaki O, Komatsu H, Sakaki T. Post-operative dexmedetomidine-based sedation after uneventful intracranial surgery for unruptured cerebral aneurysm: comparison with propofol-based sedation. Neurocrit Care. 2011 Apr;14(2):182-7. doi: 10.1007/s12028-010-9485-4.

Reference Type RESULT
PMID: 21174172 (View on PubMed)

Grof TM, Bledsoe KA. Evaluating the use of dexmedetomidine in neurocritical care patients. Neurocrit Care. 2010 Jun;12(3):356-61. doi: 10.1007/s12028-008-9156-x.

Reference Type RESULT
PMID: 20217277 (View on PubMed)

Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996 Aug;27(8):1304-5. doi: 10.1161/01.str.27.8.1304.

Reference Type RESULT
PMID: 8711791 (View on PubMed)

Topolovec-Vranic J, Canzian S, Innis J, Pollmann-Mudryj MA, McFarlan AW, Baker AJ. Patient satisfaction and documentation of pain assessments and management after implementing the adult nonverbal pain scale. Am J Crit Care. 2010 Jul;19(4):345-54; quiz 355. doi: 10.4037/ajcc2010247.

Reference Type RESULT
PMID: 20595216 (View on PubMed)

Dong R, Li F, Xu Y, Chen P, Maegele M, Yang H, Chen W. Safety and efficacy of applying sufficient analgesia combined with a minimal sedation program as an early antihypertensive treatment for spontaneous intracerebral hemorrhage: a randomized controlled trial. Trials. 2018 Nov 6;19(1):607. doi: 10.1186/s13063-018-2943-6.

Reference Type DERIVED
PMID: 30400977 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201704004

Identifier Type: -

Identifier Source: org_study_id