A Phase 4 interventional study of Remote ischemic preconditioning and Sham remote ischemic preconditioning in Acute Kidney Injury, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 7 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-07-21.
Sponsored by A.O.U. Città della Salute e della Scienza · Phase 4, Interventional, and Treatment
The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.
Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication.
Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed
1,596 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 1,110 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 64 studies on the registry; 13 are open to participants now.
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In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline
Procedure: Sham remote ischemic preconditioning
In the experimental group, patients will receive for four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg upper than baseline), followed by 5-minute intervals of reperfusion. In subjects presenting with BMI \> 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation
Procedure: Remote ischemic preconditioning
four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.
In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.
Incidence of acute kidney injury
Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration
Time frame: 24 and 48 hours after PCI
Incidence of periprocedural myocardial infarction
Time frame: 24 and 48 hours after PCI
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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A.O.U. Città della Salute e della Scienza