Remote Ischemic Preconditioning as a New Method of Nephroprotection

NCT03205410 | Completed

• 1 other identifier: RNN/286/13/KE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Kidney Injury

Keywords

remote ischemic preconditioning; cardiac surgery-associated acute kidney injury; neutrophil gelatinase-associated lipocalin

Outcome Measures

Primary Outcomes (2)

• incidence of acute kidney injury within 72 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

  72 hours after cardiac surgery

• NGAL level

  increased NGAL level within 3 hours after cardiac surgery

  3 hours after cardiac surgery

Secondary Outcomes (6)

• length of hospitalization

  through hospitalization completion, an average of 14 days

• length of intensive care unit (ICU) stay

  through ICU stay completion, an average of 5 days

• ventilation time

  through ICU stay completion, an average of 5 days

• occurrence of postoperative atrial fibrillation

  through ICU stay completion, an average of 5 days

• time of renal replacement therapy

  through ICU stay completion, an average of 5 days

Study Arms (2)

Patients with RIPC

EXPERIMENTAL

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.

Procedure: remote ischemic preconditioning

Patients without RIPC

SHAM COMPARATOR

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

Procedure: no - remote ischemic preconditioning

Interventions

remote ischemic preconditioning PROCEDURE

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

Also known as: RIPC

Patients with RIPC

no - remote ischemic preconditioning PROCEDURE

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

Also known as: no-RIPC

Patients without RIPC

Eligibility Criteria

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

You may qualify if:

• Human patients with coronary artery disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Intensive Cardiac Therapy Clinic

Lodz, 92-213, Poland

Location

Related Publications (1)

• 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.

  PMID: 32091672 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marzenna Zielinska, MD,PhD,Prof.

  Medical University of Lodz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients were randomly assigned in 1:1 ratio to either the RIPC group or the control group by means of a computerized randomization table.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: January 1, 2014
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)