Overview

This trial is active, not recruiting.

Condition acute kidney injury
Treatment remote ischemic preconditioning (ripc)
Sponsor Beijing Anzhen Hospital
Start date March 2012
End date January 2013
Trial size 310 participants
Trial identifier NCT01827891, AZ-12

Summary

This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Control participants did not experience the procedure of transient upper-limb ischemia.
(Active Comparator)
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.
remote ischemic preconditioning (ripc)
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.

Primary Outcomes

Measure
acute kidney injury
time frame: 72 hours after procedure

Secondary Outcomes

Measure
relative reduction in estimated glomerular filtration rate
time frame: 180 days after procedure

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Patients with diabetes undergoing percutaneous coronary intervention were included. Exclusion Criteria: 1. emergency PCI, 2. baseline troponin value > 0.04 ng/mL, 3. nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively), 4. patient on dialysis, 5. patients who had some inability to cooperate with the trial, 6. those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.

Additional Information

Official title Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
Description Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group. Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times. Control participants did not experience this procedure of transient upper-limb ischemia.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Beijing Anzhen Hospital.