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Remote Ischemic Preconditioning as a New Method of Nephroprotection

Not Applicable
Completed
Conditions
Acute Kidney Injury
Interventions
Procedure: remote ischemic preconditioning
Procedure: no - remote ischemic preconditioning
Registration Number
NCT03205410
Lead Sponsor
Medical University of Lodz
Brief Summary

Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).

Detailed Description

Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Human patients with coronary artery disease.
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Exclusion Criteria
  • history of cardiac surgery,
  • acute myocardial infarction up to 7 days before surgery,
  • chronic kidney disease in 4th or 5th stadium (eGFR<30 ml/min/1,73m2),
  • peripheral vascular disease affecting upper limbs,
  • history of severe injuries and surgeries in 2 months before cardiac surgery,
  • history of cancer, acute inflammation during hospitalization,
  • chronic autoimmunology diseases,
  • dialysis patients.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Patients with RIPCremote ischemic preconditioningintervention: remote ischemic preconditioning - three cycles of 5-min ischemia, achieved by inflation of blood-pressure cuff to 200 mmHg, followed by 5-min reperfusion while the cuff was deflated were applied to the upper left arm.
Patients without RIPCno - remote ischemic preconditioningintervention: no - remote ischemic preconditioning - in controls, the cuff was placed around the arm but not inflated.
Primary Outcome Measures
NameTimeMethod
incidence of acute kidney injury within 72 hours after cardiac surgery72 hours after cardiac surgery

increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery

NGAL level3 hours after cardiac surgery

increased NGAL level within 3 hours after cardiac surgery

Secondary Outcome Measures
NameTimeMethod
occurrence of postoperative atrial fibrillationthrough ICU stay completion, an average of 5 days

incidence of atrial fibrylation in continous electrocardiogram registration

ventilation timethrough ICU stay completion, an average of 5 days

time of mechanical ventilation

length of hospitalizationthrough hospitalization completion, an average of 14 days

time until discharge from the hospital

length of intensive care unit (ICU) staythrough ICU stay completion, an average of 5 days

time until discharge from ICU

time of renal replacement therapythrough ICU stay completion, an average of 5 days

days of renal replacement therapy

deathfrom date of randomization until the date of death from any cause, assessed up to 2 years

death from any cause

Trial Locations

Locations (1)

Intensive Cardiac Therapy Clinic

🇵🇱

Lodz, Poland

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