Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Injury During Cardiopulmonary Bypass

NCT01144585 | Completed DMC

• 1 other identifier: H-1001-016-306
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Remote Ischemic Preconditioning(RIPC) and remote ischemic postconditioning(RIPoC) seems to have a protective effect during ischemic period. Using cardiopulmonary bypass(CPB) during open heart surgery reduces pulmonary blood flow and may cause ischemic damage to lung tissue. The investigators anticipate that RIPC and RIPoC may reduce lung injury after CPB.

Conditions

Acute Lung Injury

Keywords

RIPC; lung protection; ischemic reperfusion injury; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• arterial partial pressure of oxygen divided by fraction of inspired oxygen

  follow up PaO2/FiO2 during operation and after the opreation for 24 hours

  within 24hr after the surgery

Secondary Outcomes (1)

• plasma cytokines

  within 24hr after the surgery

Study Arms (2)

RIPC

EXPERIMENTAL

those who receive RIPC and RIPoC before and after CPB

Procedure: remote ischemic preconditioning and postconditioning

Control

PLACEBO COMPARATOR

this group have same pneumatic cuff around their arm, but it is not inflated.

Procedure: Control

Interventions

remote ischemic preconditioning and postconditioning PROCEDURE

RIPC is done before the use of CPB. It consists of 4 cycles of 5 minutes inflation of pneumatic cuff to 200 mmHg and deflation for 5 minutes. RIPoC is exactly same procedure done "after" CPB.

RIPC

Control PROCEDURE

This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery

Control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• those who aged 18-80 years old and planned to undergo elective open heart surgery using cardiopulmonary bypass

You may not qualify if:

• emergent operation
• preoperative use of inotropics or mechanical assist device,
• left ventricular ejection fraction less than 30%,
• severe liver, renal disease,
• recent myocardial infarction (within 7 days),
• recent systemic infection or sepsis (within 7 days)
• peripheral vascular disease affecting upper limbs
• amputation of the upper limbs
• major combined operation such as aortic surgery or carotid endarterectomy
• descending thoracic aortic surgery
• rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc
• significantly decreased pulmonary function before the planned surgery (e.g. using ventilator, oxygen therapy, tachypnea, orthopnea, active lung lesion on chest X-ray, FEV1/FVC less than 50% of predicted level, PaO2 less than 80 mmHg)
• intracardiac shunt
• severe pulmonary artery hypertension
• systemic or local steroid therapy

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• YunSeok Jeon, MD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 15, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

KR (1)