Contrast Induced - Acute Kidney Injury, Remote Ischemic Preconditioning
Conditions
Keywords
remote ischemic preconditioning, contrast induced-acute kidney injury, neutrophil gelatinase-associated lipocalin, percutaneous coronary intervention
Brief 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.
Interventions
PROCEDURERemote Ischemic Preconditioning
four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff
PROCEDURESham Remote Ischemic Preconditioning
deflated cuff placed on the left arm for 40 min
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged over 18 years * patients with stable angina pectoris * patients admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz with intention of elective CA with follow-up PCI.
Exclusion criteria
* history of severe injuries up to 2 months before intervention * history of surgeries up to 2 months before intervention * history of cancer, * acute inflammation during hospitalization * chronic autoimmunologic diseases * patients needing hemodialysis * chronic kidney disease in stage 4 or 5 (eGFR\<30 ml/min/1,73m2) * peripheral vascular disease affecting upper limbs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Contrast Induced-Acute Kidney Injury | 48 to 72 hours after contrast exposure | absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Need of Renal Replacement Therapy | up to 7 days after contrast exposure | qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management) |
| Number of Participants Who Presented Cardiogenic Shock | up to 7 days after contrast exposure | sustained hypotension (systolic blood pressure \< 90 mm Hg for ≥30 min) |
| Death of Any Cause | up to one month after contrast exposure | Number of patients who died. |
Countries
Poland
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 51 |
| Total | 101 |
Baseline characteristics
| Characteristic | Total | RIPC Group | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 23 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 27 Participants | 26 Participants |
| Contrast Medium Intake | 110 ml | 100 ml | 110 ml |
| NGAL on admission | 74.4 ng/mL | 71.3 ng/mL | 80.6 ng/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 101 Participants | 50 Participants | 51 Participants |
| Serum creatinine on admission | 88 µmol/L | 87 µmol/L | 88 µmol/L |
| Sex: Female, Male Female | 35 Participants | 17 Participants | 18 Participants |
| Sex: Female, Male Male | 66 Participants | 33 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 1 / 50 | 0 / 51 |
| serious Total, serious adverse events | 1 / 50 | 1 / 51 |
Outcome results
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
Time frame: 48 to 72 hours after contrast exposure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIPC Group | Number of Participants With Contrast Induced-Acute Kidney Injury | 2 participants |
| Control Group | Number of Participants With Contrast Induced-Acute Kidney Injury | 3 participants |
Secondary
Death of Any Cause
Number of patients who died.
Time frame: up to one month after contrast exposure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIPC Group | Death of Any Cause | 0 participants |
| Control Group | Death of Any Cause | 0 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIPC Group | Number of Participants Who Presented Cardiogenic Shock | 1 participants |
| Control Group | Number of Participants Who Presented Cardiogenic Shock | 1 participants |
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)
Time frame: up to 7 days after contrast exposure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIPC Group | Number of Participants With Need of Renal Replacement Therapy | 0 participants |
| Control Group | Number of Participants With Need of Renal Replacement Therapy | 0 participants |