Remote Ischemic Preconditioning as a New Method of Nephroprotection

Medical University of Lodz

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Procedure: remote ischemic preconditioning; Procedure: no - remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03205410

RNN/286/13/KE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Human patients with coronary artery disease.

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Patients with RIPC

Experimental group

Description:

intervention: 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.

Treatment:

Procedure: remote ischemic preconditioning

Patients without RIPC

Sham Comparator group

Description:

intervention: no - remote ischemic preconditioning - in controls, the cuff was placed around the arm but not inflated.

Treatment:

Procedure: no - remote ischemic preconditioning