Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia

N/ACompletedNCT05982015

Capital Medical University1,651 enrolled

Overview

Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset

Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,651

Conditions

Stroke

Interventions

Remote ischemic conditioningDEVICE

The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.

Sham remote ischemic conditioningDEVICE

The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age≥18 years old; * Diagnosis of acute ischemic stroke; * Remote ischemic conditioning or sham-remote ischemic conditioning can be treated within 24 hours after stroke onset * NIHSS score≥4; * Subject or his or her legally authorized representative was able to provide informed consent. Exclusion Criteria: * During the screening period, body temperature ≥ 38 ℃; * Evidence of lung infection, urinary tract infection or other infectious diseases during the screening period * Expected lifespan less than 7 days * Mechanical ventilation is expected to be required within 7 days; * Anti-infective drug were used within 7 days prior to stroke; * Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg); * There are contraindications for remote ischemic conditioning (such as skin and soft tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs); * History of autoimmune disease or malignancies; * Use of immunosuppressive drug within the preceding 3 months; * Pregnant or lactating, or pregnancy test positive; * Current participation in another investigational trial; * Other conditions are not suitable for this trial as evaluated by researchers.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Stroke-associated pneumonia

Stroke-associated pneumonia incidence rate

Time frame: 7 days

Secondary Outcomes

Physician diagnosed pneumonia

Physician diagnosed pneumonia incidence rate

Time frame: 7 days

Physician diagnosed pneumonia

Physician diagnosed pneumonia incidence rate

Time frame: 8-90 days

Modified Rankin scale score from 0 to 1

In medical and clinical research, the modified Rankin Scale (mRS) is used to assess the degree of disability in patients after a stroke. The scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. On the mRS scale, scores from 0 to 2 usually indicate no or slight disability. Specifically: 0 points: No symptoms. 1. point: Symptoms present but no significant disability; able to carry out all usual duties and activities. 2. points: Slight disability; able to look after own affairs without assistance but unable to carry out all previous activities. Therefore, in clinical research, if a treatment or intervention increases the proportion of patients scoring 0 to 1 on the mRS scale, it is generally considered a positive outcome. This means that more patients have a better functional status and lower degree of disability after treatment.

Time frame: 90 days after the onset of symptoms

Modified Rankin scale score from 0 to 2

In medical and clinical research, the modified Rankin Scale (mRS) is used to assess the degree of disability in patients after a stroke. The scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. On the mRS scale, scores from 0 to 2 usually indicate no or slight disability. Specifically: 0 points: No symptoms. 1. point: Symptoms present but no significant disability; able to carry out all usual duties and activities. 2. points: Slight disability; able to look after own affairs without assistance but unable to carry out all previous activities. Therefore, in clinical research, if a treatment or intervention increases the proportion of patients scoring 0 to 2 on the mRS scale, it is generally considered a positive outcome. This means that more patients have a better functional status and lower degree of disability after treatment.

Data from ClinicalTrials.gov

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