Trial Outcomes & Findings for Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI (NCT NCT03761368)
NCT ID: NCT03761368
Last Updated: 2020-11-19
Results Overview
absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
48 to 72 hours after contrast exposure
Results posted on
2020-11-19
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
50
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI
Baseline characteristics by cohort
| Measure |
RIPC Group
n=50 Participants
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
|
Control Group
n=51 Participants
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Contrast Medium Intake
|
100 ml
n=5 Participants
|
110 ml
n=7 Participants
|
110 ml
n=5 Participants
|
|
Serum creatinine on admission
|
87 µmol/L
n=5 Participants
|
88 µmol/L
n=7 Participants
|
88 µmol/L
n=5 Participants
|
|
NGAL on admission
|
71.3 ng/mL
n=5 Participants
|
80.6 ng/mL
n=7 Participants
|
74.4 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 to 72 hours after contrast exposureabsolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline
Outcome measures
| Measure |
RIPC Group
n=50 Participants
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
|
Control Group
n=51 Participants
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
|
|---|---|---|
|
Number of Participants With Contrast Induced-Acute Kidney Injury
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: up to 7 days after contrast exposurequalification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)
Outcome measures
| Measure |
RIPC Group
n=50 Participants
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
|
Control Group
n=51 Participants
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
|
|---|---|---|
|
Number of Participants With Need of Renal Replacement Therapy
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 7 days after contrast exposuresustained hypotension (systolic blood pressure \< 90 mm Hg for ≥30 min)
Outcome measures
| Measure |
RIPC Group
n=50 Participants
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
|
Control Group
n=51 Participants
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
|
|---|---|---|
|
Number of Participants Who Presented Cardiogenic Shock
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to one month after contrast exposureNumber of patients who died.
Outcome measures
| Measure |
RIPC Group
n=50 Participants
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
|
Control Group
n=51 Participants
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
|
|---|---|---|
|
Death of Any Cause
|
0 participants
|
0 participants
|
Adverse Events
RIPC Group
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RIPC Group
n=50 participants at risk
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
|
Control Group
n=51 participants at risk
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
|
|---|---|---|
|
Cardiac disorders
Cardiogenic shock
|
2.0%
1/50 • up to one month
|
2.0%
1/51 • up to one month
|
Other adverse events
| Measure |
RIPC Group
n=50 participants at risk
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
|
Control Group
n=51 participants at risk
Patients from control group had sham Remote Ischemic Preconditioning.
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin petechiae
|
2.0%
1/50 • Number of events 1 • up to one month
|
0.00%
0/51 • up to one month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place