Trials / Completed
CompletedNCT03205410
Remote Ischemic Preconditioning as a New Method of Nephroprotection
Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Medical University of Lodz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | remote ischemic preconditioning | The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery. |
| PROCEDURE | 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. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-12-31
- Completion
- 2014-12-31
- First posted
- 2017-07-02
- Last updated
- 2017-07-02
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT03205410. Inclusion in this directory is not an endorsement.