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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC group | Experimental | The RIPC group underwent Remote Ischemic Preconditioning. |
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| Control group | Sham Comparator | Patients from control group had sham Remote Ischemic Preconditioning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Preconditioning | Procedure | four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 to 72 hours after contrast exposure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 7 days after contrast exposure |
| Number of Participants Who Presented Cardiogenic Shock |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marzenna Zielinska, MD PhD | Medical University of Lodz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Cardiac Therapy Clinic | Lodz | 92-213 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32874376 | Derived | Stokfisz K, Ledakowicz-Polak A, Kidawa M, Zielinska M. Remote Ischemic Preconditioning and Contrast-Induced Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention: A Randomized Clinical Trial. Curr Ther Res Clin Exp. 2020 Aug 5;93:100599. doi: 10.1016/j.curtheres.2020.100599. eCollection 2020. |
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The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
3 years after the end of the study
on reasonable request
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | RIPC Group | The RIPC group underwent Remote Ischemic Preconditioning. Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff |
| FG001 | Control Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2018 | Oct 8, 2020 |
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After admission to the Department, patients were randomly assigned in 1:1 ratio to either control group or RIPC - group by means of a computerized randomization table.
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Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.
| Sham Remote Ischemic Preconditioning | Procedure | deflated cuff placed on the left arm for 40 min |
|
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sustained hypotension (systolic blood pressure < 90 mm Hg for ≥30 min) |
| up to 7 days after contrast exposure |
| Death of Any Cause | Number of patients who died. | up to one month after contrast exposure |
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RIPC Group | The RIPC group underwent Remote Ischemic Preconditioning. Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left arm cuff |
| BG001 | Control Group | Patients from control group had sham Remote Ischemic Preconditioning. Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Contrast Medium Intake | Median | Inter-Quartile Range | ml |
| |||||||||||||||||
| Serum creatinine on admission | Median | Inter-Quartile Range | µmol/L |
| |||||||||||||||||
| NGAL on admission | Median | Inter-Quartile Range | ng/mL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 48 to 72 hours after contrast exposure |
|
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| ||||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Number | participants | up to 7 days after contrast exposure |
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| Secondary | Number of Participants Who Presented Cardiogenic Shock | sustained hypotension (systolic blood pressure < 90 mm Hg for ≥30 min) | Posted | Number | participants | up to 7 days after contrast exposure |
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| Secondary | Death of Any Cause | Number of patients who died. | Posted | Number | participants | up to one month after contrast exposure |
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up to one month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RIPC Group | The RIPC group underwent Remote Ischemic Preconditioning. Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper-arm cuff | 0 | 50 | 1 | 50 | 1 | 50 |
| EG001 | Control Group | Patients from control group had sham Remote Ischemic Preconditioning. Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min | 0 | 51 | 1 | 51 | 0 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment | petechiae on the skin of preconditioned arm distally to upper - arm cuff placement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karolina Stokfisz | Medical University of Łódź | +48422014260 | stokfisz.karolina@gmail.com |
| SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 1, 2018 | Nov 2, 2020 | Prot_002.pdf |
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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