Trials / Completed
CompletedNCT03761368
Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI
Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Medical University of Lodz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).
Detailed description
Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of 25% in serum creatinine compared to baseline within 48 to 72 hours after contrast administration. In the last decades, several novel biomarkers of AKI have been studied including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic preconditioning (RIPC) turned out to be one of the most promising and intriguing non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs from subsequent injury.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Remote Ischemic Preconditioning | four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff |
| PROCEDURE | Sham Remote Ischemic Preconditioning | deflated cuff placed on the left arm for 40 min |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2018-06-30
- Completion
- 2018-06-30
- First posted
- 2018-12-03
- Last updated
- 2020-11-19
- Results posted
- 2020-10-30
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT03761368. Inclusion in this directory is not an endorsement.