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Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cai Li, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01344239
First received: April 26, 2011
Last updated: May 11, 2013
Last verified: May 2013
History of Changes
  Purpose

To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.


Condition Intervention
Abdominal Aortic Aneurysm
 Procedure: Limb remote ischemic preconditioning(LRIP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair:A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing elective open abdominal aortic aneurysm repair [ Time Frame: June,2011 ] [ Designated as safety issue: Yes ]
    Compared with the control group, patients in the LRIP group had significantly higher Cs and Cd , along with lower PA-aDO2 and RI at various phase (P<0.05). Serum concentration of IL-6,IL-8, TNF-ɑ and MDA in LRIP group were decreased significantly at postoperative time points compared with those in control group (P<0.05), but SOD was increased significantly at the same time (P<0.05). Patient's ventilator support time and duration of ICU stay in LRIP group were shorter than that in control group (P<0.05)


Enrollment: 62
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Limb RIPC
The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.
 Procedure: Limb remote ischemic preconditioning(LRIP)
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.
Other Name: LRIP
No Intervention: convention
Adult patients undergoing elective open abdominal aortic aneurysm repair received no treatment after induction of anaesthesia

Detailed Description:

Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and diamine oxidase activity) and the variables reflecting pulmonary injury (arterial-alveolar oxygen tension ratio, alveolar-arterial oxygen tension difference and respiratory index). In addition, the severity of intestinal and pulmonary injury was assessed with different scoring methods, respectively. Markers of oxidative stress and systemic inflammation were measured as well.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  • history of inflammatory bowel disease
  • history of diarrhea (≥2 liquid stools per day for ≥2 days) within 1 week of surgery
  • intestinal chronic inflammatory disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344239

Sponsors and Collaborators
Cai Li
Investigators
Principal Investigator: Ke-Xuan Liu, Ph.D First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Cai Li, Department of Anesthesiology,First Affiliated Hospital, Sun Yat-Sen University, Department of Anesthesiology,First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01344239     History of Changes
Other Study ID Numbers: LRIP701126, CLi
Study First Received: April 26, 2011
Last Updated: May 11, 2013
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
aortic aneurysm
ischemia/reperfusion
preconditioning
pulmonary injury
intestinal injury

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Lung Injury
Vascular Diseases
Cardiovascular Diseases
 Aortic Diseases
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013