Remote Ischemic Preconditioning as a New Method of Nephroprotection

Acute Kidney Injury Clinical Trial

Official title:

Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205410
• Other study ID #: RNN/286/13/KE
• Status: Completed
• Phase: N/A
• First received: June 29, 2017
• Last updated: June 29, 2017
• Start date: January 1, 2014
• Est. completion date: December 31, 2014

Study information

• Verified date: June 2017
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
Poland	Intensive Cardiac Therapy Clinic	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	NGAL level	increased NGAL level within 3 hours after cardiac surgery	3 hours after cardiac surgery
Secondary	length of hospitalization	time until discharge from the hospital	through hospitalization completion, an average of 14 days
Secondary	length of intensive care unit (ICU) stay	time until discharge from ICU	through ICU stay completion, an average of 5 days
Secondary	ventilation time	time of mechanical ventilation	through ICU stay completion, an average of 5 days
Secondary	occurrence of postoperative atrial fibrillation	incidence of atrial fibrylation in continous electrocardiogram registration	through ICU stay completion, an average of 5 days
Secondary	time of renal replacement therapy	days of renal replacement therapy	through ICU stay completion, an average of 5 days
Secondary	death	death from any cause	from date of randomization until the date of death from any cause, assessed up to 2 years