RICA-2: Remote Ischemic Conditioning for Stroke-associated Pneumonia
Study Details
Study Description
Brief Summary
Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group Remote ischemic conditioning (RIC) -200mmHg and best medical management |
Device: Remote ischemic conditioning
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 Comparator: Sham group Remote ischemic conditioning (RIC) -60mmHg and best medical management |
Device: Sham remote ischemic conditioning
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.
|
Outcome Measures
Primary Outcome Measures
- Stroke-associated pneumonia [7 days]
Stroke-associated pneumonia incidence rate
Secondary Outcome Measures
- Physician diagnosed pneumonia [7 days]
Physician diagnosed pneumonia incidence rate
- Physician diagnosed pneumonia [8-90 days]
Physician diagnosed pneumonia incidence rate
- Modified Rankin scale 0-1 [90 days after the onset of symptoms]
defined by 0-1 of the modified Rankin Scale (mRS)
- Modified Rankin scale 0-2 [90 days]
defined by 0-2 of the modified Rankin Scale (mRS)
- Modified Rankin scale [90 days]
Shift analysis
- EQ-5D-5L [90 days]
The score of EQ-5D-5L
- NIHSS stroke scale [24 hours]
The score of NIHSS stroke scale
- NIHSS stroke scale [7 days]
The score of NIHSS stroke scale
- Urinary tract infections [7 days]
Urinary tract infections incidence rate
- Infections [7 days]
Infections incidence rate
- All-cause mortality [90 days]
All-cause mortality incidence rate
- Inpatient days [90 days]
Total inpatient days
Other Outcome Measures
- Spots of skin bleeding within 7 days [7 days]
Number of subjects who have skin bleeding points within 7 days
- Red or swollen arms within 7 days [7 days]
Number of subjects who have red or swollen arms within 7 days
- Dizziness within 7 days [7 days]
Number of subjects who have dizziness within 7 days
- Nausea within 7 days [7 days]
Number of subjects who have nausea within 7 days
- Palpitations within 7 days. [7 days]
Number of subjects who have palpitations within 7 days.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Capital Medical University
Investigators
- Study Director: Chuanjie Wu, M.D., Xuanwu Hospital of Capital Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.
- Chamorro A, Urra X, Planas AM. Infection after acute ischemic stroke: a manifestation of brain-induced immunodepression. Stroke. 2007 Mar;38(3):1097-103. doi: 10.1161/01.STR.0000258346.68966.9d. Epub 2007 Jan 25.
- Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.
- Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.
- Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.
- Randhawa PK, Bali A, Jaggi AS. RIPC for multiorgan salvage in clinical settings: evolution of concept, evidences and mechanisms. Eur J Pharmacol. 2015 Jan 5;746:317-32. doi: 10.1016/j.ejphar.2014.08.016. Epub 2014 Aug 28.
- Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.
- RICA-2