An interventional study of Remote Ischemic Preconditioning and Sham Remote Ischemic Preconditioning in Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Prevention
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).
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 101 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Medical University of Lodz is the lead sponsor of 101 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The RIPC group underwent Remote Ischemic Preconditioning.
Procedure: Remote Ischemic Preconditioning
Patients from control group had sham Remote Ischemic Preconditioning.
Procedure: Sham Remote Ischemic Preconditioning
four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff
Also known as: RIPC
deflated cuff placed on the left arm for 40 min
Also known as: Sham RIPC
Number of Participants With Contrast Induced-Acute Kidney Injury
absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline
Time frame: 48 to 72 hours after contrast exposure
Number of Participants With Need of Renal Replacement Therapy
qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)
Time frame: up to 7 days after contrast exposure
Number of Participants Who Presented Cardiogenic Shock
sustained hypotension (systolic blood pressure \< 90 mm Hg for ≥30 min)
Time frame: up to 7 days after contrast exposure
Death of Any Cause
Number of patients who died.
Time frame: up to one month after contrast exposure
Patients aged over 18 years presented with stable angina pectoris, admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz and scheduled for elective CA with follow-up PCI.
| Milestone | RIPC Group | Control Group |
|---|---|---|
| Started | 50 | 51 |
| Completed | 50 | 51 |
| Not completed | 0 | 0 |
absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline
| participants | RIPC Group | Control Group |
|---|---|---|
| Number of Participants With Contrast Induced-Acute Kidney Injury | 2 | 3 |
qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)
| participants | RIPC Group | Control Group |
|---|---|---|
| Number of Participants With Need of Renal Replacement Therapy | 0 | 0 |
sustained hypotension (systolic blood pressure \< 90 mm Hg for ≥30 min)
| participants | RIPC Group | Control Group |
|---|---|---|
| Number of Participants Who Presented Cardiogenic Shock | 1 | 1 |
Number of patients who died.
| participants | RIPC Group | Control Group |
|---|---|---|
| Death of Any Cause | 0 | 0 |
Collected over up to one month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RIPC Group | 0/50 (0%) | 1/50 (2%) | 1/50 (2%) |
| Control Group | 0/51 (0%) | 1/51 (2%) | 0/51 (0%) |
| Event | RIPC Group | Control Group |
|---|---|---|
| Cardiogenic shockCardiac disorders | 1/50 | 1/51 |
| Event | RIPC Group | Control Group |
|---|---|---|
| skin petechiaeSkin and subcutaneous tissue disorders | 1/50 | 0/51 |
| Age, Categorical(Participants) | RIPC Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 26 | 53 |
| >=65 years | 23 | 25 | 48 |
| Sex: Female, Male(Participants) | RIPC Group | Control Group | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 33 | 33 | 66 |
| Race (NIH/OMB)(Participants) | RIPC Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 50 | 51 | 101 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Contrast Medium Intake(ml) | RIPC Group | Control Group | Total |
|---|---|---|---|
| Median | 100 (80 to 140) | 110 (90 to 140) | 110 (80 to 140) |
| Serum creatinine on admission(µmol/L) | RIPC Group | Control Group | Total |
|---|---|---|---|
| Median | 87 (81 to 96) | 88 (82 to 101) | 88 (81 to 99) |
| NGAL on admission(ng/mL) | RIPC Group | Control Group | Total |
|---|---|---|---|
| Median | 71.3 (55.8 to 86.8) | 80.6 (55.8 to 101.2) | 74.4 (55.8 to 102.3) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr
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Medical University of Lodz