NCT03207100

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 6, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

June 26, 2017

Last Update Submit

December 5, 2023

Conditions

Early Systolic Blood Pressure Control RateHematoma GrowthBlood Pressure VariabilityHealthcare Worker SatisfactionDuration of ICU Treatment and Mechanical Ventilation

Keywords

Intracerebral hemorrhageEarly antihypertensive treatmentAnalgesia-firstSedation

Outcome Measures

Primary Outcomes (1)

  • Systolic BP control rate at 1h post-treatment initiation

    The number of patients who systolic BP decreased to \<140 mmHg at 1h post-treatment initiation compared to the total number of each group.

    1h post-treatment initiation

Secondary Outcomes (8)

  • Hematoma growth at 24 h

    24h of treatment

  • BP variability

    Up to 7 days

  • Neurologic function

    Up to 7 days

  • Duration of ICU treatment and mechanical ventilation

    Up to 7 days

  • Healthcare worker satisfaction

    7 day or discharge from ICU (if patients discharge from ICU in 7 days)

  • +3 more secondary outcomes

Study Arms (2)

Analgesia-first minimal sedation group

EXPERIMENTAL

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

Combination Product: Analgesia-first minimal sedation

Antihypertensive drug treatment group

ACTIVE COMPARATOR

Using routine antihypertensive drugs to implement antihypertensive therapy.

Combination Product: Antihypertensive treatment

Interventions

Analgesia-first minimal sedationCOMBINATION_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.

Analgesia-first minimal sedation group
Antihypertensive treatmentCOMBINATION_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.

Antihypertensive drug treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subject has contraindications for emergency intensified antihypertensive treatment;
  • Intracranial hemorrhage secondary to intracranial tumor, recent trauma, cerebral infarction and thrombolytic therapy;
  • History of ischemic stroke within 30 days before disease onset;
  • Clinical or imaging examination reveals an expected high mortality in subject within the next 24h;
  • Presence of dementia or significant post-stroke disability;
  • Coagulation disorder caused by drugs or hematologic diseases;
  • Allergy to opioids;
  • Interference test result, assessment and follow-up of comorbidity;
  • Presence of sinus arrest, borderline rhythm, grade II and above atrioventricular block and malignant arrhythmia;
  • Individual is pregnant or lactating;
  • Currently participating in other drug studies or clinical trials;
  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Guangdong 999 Brain Hospital

Guangzhou, Guangdong, 510000, China

Location

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510630, China

Location

The Fifth Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510900, China

Location

MaoMing People's Hospital

Maoming, Guangdong, 525000, China

Location

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, 518035, China

Location

Zhongshan People's Hospital

Zhongshan, Guangdong, 528400, China

Location

The Fifth Affiliated Hospital Sun-yet sen University

Zhuhai, Guangdong, 519000, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

The Second Hospital University of South China

Hengyang, Hunan, 421001, China

Location

The First Affiliated Hospital of HuNan University of Medicine

Huaihua, Hunan, 418000, China

Location

Qilu Hospital of Shandong University

Qingdao, Shandong, 266035, China

Location

The First Affiliated Hospital of Xinjiang Medical University

ĂœrĂ¼mqi, Xinjiang, 830054, China

Location

The First Affiliated Hospital of Kuming Medical University

Kunming, Yunnan, 650032, China

Location

Related Publications (43)

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    PMID: 30400977DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wen-Jin Chen

    Xuanwu Hospital, Beijing

    STUDY CHAIR

  • Hong Yang, Dr

    The Third Affiliated Hospital of Southern Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study uses a single-blinded design in which only the investigators and not the subjects know the method of intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor of Medicine (M.D.)ï¼›Associate Senior Doctor

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

December 6, 2017

Primary Completion

February 14, 2021

Study Completion

May 15, 2021

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(17)