Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery

NCT03010839 | Completed DMC

• 1 other identifier: XYFY-2017-001
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.The heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent some trials suggested that RIPC could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies\[9-11\] had failed to show the protective effects of RIPC with respect to the troponin release and lung injury. Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified RIPC protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.

Conditions

Myocardial Injury; Remote Ischemic Preconditioning

Outcome Measures

Primary Outcomes (1)

• Troponin I serum release over 24 hours after surgery

  24 hours post surgery

Secondary Outcomes (3)

• PaO2/FiO2 ratio over 24 hours after surgery

  24 hours post surgery

• salveolar-arterial oxygen gradient over 24 hours after surgery

  24 hours post surgery

• Inotrope score

  12 hours post surgery

Study Arms (2)

Modified Remote Ischemic Preconditioning(mRIPC)

ACTIVE COMPARATOR

modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC. The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.

Procedure: Modified Remote Ischemic Preconditioning

Control

PLACEBO COMPARATOR

Control group without remote ischemic preconditioning

Procedure: Control

Interventions

Modified Remote Ischemic Preconditioning PROCEDURE

mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg

Also known as: mRIPC

Modified Remote Ischemic Preconditioning(mRIPC)

Control PROCEDURE

Control group witnout remote ischemic preconditioning

Control

Eligibility Criteria

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

You may qualify if:

• Patients undergoing heart surgery on cardiopulmonary bypass
• Patients aged 18 years to 80 years

You may not qualify if:

• Inability to give informed consent
• Cardiogenic shock
• Cardiac arrest on current admission
• Left ventricular ejection fraction less than 30%
• Current atrial fibrillation
• Preoperative use of inotropics or mechanical assist device
• Patients with significant hepatic dysfunction (Prothrombin\>2.0 ratio)
• Patients with known renal failure with a GFR\<30 mL/min/1.73 m2
• Patients with significant pulmonary disease (FEV1\<40% predicted)
• Recent myocardial infarction (within 7 days)
• Recent systemic infection or sepsis (within 7 days)
• Severe stroke (within 2 months)
• Significant peripheral arterial disease affecting the upper limbs
• Previous serious psychiatric disorders (e.g. schizophrenia, dementia)
• Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Related Publications (28)

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Study Officials

• Liu Su, M.D/Ph.D

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D/Ph.D

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 5, 2017
• Study Start: November 5, 2016
• Primary Completion: January 10, 2018
• Study Completion: March 10, 2018
• Last Updated: March 19, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)