Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Impact of Limb Remote Ischemic Preconditioning on Mortality, Hospitalization Costs and Quality of Life During Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01910961
• Other study ID #: LRIP
• Secondary ID: Liu Kexuan
• Status: Not yet recruiting
• Phase: N/A
• First received: June 27, 2013
• Last updated: July 26, 2013
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: July 2013
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Cai Li, MD
• Phone: +86-18602017796
• Email: licaigz[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality, hospitalization costs and quality of life in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.

Description:

Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators have revealed that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.Few groups have investigated the long term influence of limb remote ischemic preconditioning.Therefore, the investigators evaluated the impact of limb remote ischemic preconditioning on mortality, hospitalization costs and quality of life during elective abdominal aortic aneurysm repair in a prospective, randomized, controlled, single blind setting.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of abdominal aortic aneurysm

• Must be received open abdominal aortic aneurysm repair

Exclusion Criteria:

• age >80 years old

• Acute coronary syndrome or myocardial infraction within 3 months

• Chronic obstructive pulmonary emphysema

• angina pain within 48 hours of repair procedure

• ejection fraction less than 40%

• poor pulmonary function (PaO2 <60mmHg)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• limb RIPC
LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Cai Li	Huazhong University of Science and Technology, West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year	No
Secondary	hospitalization costs		30 days after operation	No