Acute Kidney Injury
Conditions
Keywords
remote ischemic preconditioning, cardiac surgery-associated acute kidney injury, neutrophil gelatinase-associated lipocalin
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.
Interventions
PROCEDUREremote ischemic preconditioning
The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
PROCEDUREno - remote ischemic preconditioning
The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Patients were randomly assigned in 1:1 ratio to either the RIPC group or the control group by means of a computerized randomization table.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of acute kidney injury within 72 hours after cardiac surgery | 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 |
| NGAL level | 3 hours after cardiac surgery | increased NGAL level within 3 hours after cardiac surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ventilation time | through ICU stay completion, an average of 5 days | time of mechanical ventilation |
| occurrence of postoperative atrial fibrillation | through ICU stay completion, an average of 5 days | incidence of atrial fibrylation in continous electrocardiogram registration |
| length of hospitalization | through hospitalization completion, an average of 14 days | time until discharge from the hospital |
| death | from date of randomization until the date of death from any cause, assessed up to 2 years | death from any cause |
| time of renal replacement therapy | through ICU stay completion, an average of 5 days | days of renal replacement therapy |
| length of intensive care unit (ICU) stay | through ICU stay completion, an average of 5 days | time until discharge from ICU |
Countries
Poland
Outcome results
None listed