Clinical trial NCT03205410: Remote Ischemic Preconditioning as a New Method of Nephroprotection
Official title: Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: remote ischemic preconditioning
cardiac surgery-associated acute kidney injury
neutrophil gelatinase-associated lipocalin
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: incidence of acute kidney injury within 72 hours after cardiac surgery
timeFrame: 72 hours after cardiac surgery
measure: NGAL level
timeFrame: 3 hours after cardiac surgery
Secondary outcomes:
measure: length of hospitalization
timeFrame: through hospitalization completion, an average of 14 days
measure: length of intensive care unit (ICU) stay
timeFrame: through ICU stay completion, an average of 5 days
measure: ventilation time
timeFrame: through ICU stay completion, an average of 5 days
measure: occurrence of postoperative atrial fibrillation
timeFrame: through ICU stay completion, an average of 5 days
measure: time of renal replacement therapy
timeFrame: through ICU stay completion, an average of 5 days
measure: death
timeFrame: from date of randomization until the date of death from any cause, assessed up to 2 years
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Intensive Cardiac Therapy Clinic
Study officials:
affiliation: Medical University of Lodz
name: Marzenna Zielinska, MD,PhD,Prof.
role: STUDY_CHAIR
References:
citation: 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.