Remote Ischemic Preconditioning as a New Method of Nephroprotection

NCT ID: NCT03205410

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2014-12-31

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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patients with RIPC

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.

Group Type: EXPERIMENTAL

remote ischemic preconditioning

Intervention Type: PROCEDURE

The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.

Patients without RIPC

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

Group Type: SHAM_COMPARATOR

no - remote ischemic preconditioning

Intervention Type: PROCEDURE

The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.

Interventions

remote ischemic preconditioning

The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.

Intervention Type: PROCEDURE

no - remote ischemic preconditioning

The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.

Intervention Type: PROCEDURE

Other Intervention Names

RIPC; no-RIPC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Karolina Stokfisz

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marzenna Zielinska, MD,PhD,Prof.

Role: STUDY_CHAIR

Medical University of Lodz

Locations

Intensive Cardiac Therapy Clinic

Lodz, , Poland

Countries

Poland

References

Stokfisz K, Ledakowicz-Polak A, Zagorski M, Jander S, Przybylak K, Zielinska M. The clinical utility of remote ischemic preconditioning in protecting against cardiac surgery-associated acute kidney injury: A pilot randomized clinical trial. Adv Clin Exp Med. 2020 Feb;29(2):189-196. doi: 10.17219/acem/112610.

Reference Type: DERIVED

PMID: 32091672 (View on PubMed)

Other Identifiers

RNN/286/13/KE

Identifier Type: -

Identifier Source: org_study_id