Remote Ischemic PreconditioningNCT03761368
Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI
A study testing Remote Ischemic Preconditioning in people with Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Remote Ischemic Preconditioning, Contrast Induced - Acute Kidney Injury
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial
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).
Read the 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.
- Being tested
- Remote Ischemic Preconditioning, Sham Remote Ischemic Preconditioning
- Keywords
- remote ischemic preconditioning, contrast induced-acute kidney injury, neutrophil gelatinase-associated lipocalin, percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
Also called RIPC
four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff
Sham Remote Ischemic PreconditioningProcedure or surgery
Also called Sham RIPC
deflated cuff placed on the left arm for 40 min
| Study group | Role | What they receive |
|---|---|---|
| RIPC group | Experimental | The RIPC group underwent Remote Ischemic Preconditioning. Receives: Procedure: Remote Ischemic Preconditioning |
| Control group | Sham comparator | Patients from control group had sham Remote Ischemic Preconditioning. Receives: Procedure: Sham Remote Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 to 72 hours after contrast exposure
Secondary outcomes (3)
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)
Measured: 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)
Measured: up to 7 days after contrast exposure
Death of Any Cause
Number of patients who died.
Measured: up to one month after contrast exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Mar 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Remote Ischemic PreconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Stokfisz, Medical University of Lodz
- Investigators
- Marzenna Zielinska, MD PhD, Study chair, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761368
- Sponsor's protocol ID
- RNN/219/13/KE
- Status last verified
- Nov 2018
- First submitted
- 29 Nov 2018
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 32874376
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03761368
- Acronym / sponsor ID
- RNN/219/13/KE
- Keywords
- remote ischemic preconditioning, contrast induced-acute kidney injury, neutrophil gelatinase-associated lipocalin, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 30 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| RIPC group | Experimental | Procedure: Remote Ischemic PreconditioningThe RIPC group underwent Remote Ischemic Preconditioning. |
| Control group | Sham comparator | Procedure: Sham Remote Ischemic PreconditioningPatients from control group had sham Remote Ischemic Preconditioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic PreconditioningAlso: RIPCfour cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff | Procedure or surgery | RIPC group |
| Sham Remote Ischemic PreconditioningAlso: Sham RIPCdeflated cuff placed on the left arm for 40 min | Procedure or surgery | Control group |
Primary outcome
Number of Participants With Contrast Induced-Acute Kidney Injury
Time frame: 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
3 secondary outcomes
Number of Participants With Need of Renal Replacement Therapy
Time frame: up to 7 days after contrast exposure
Number of Participants Who Presented Cardiogenic Shock
Time frame: up to 7 days after contrast exposure
Death of Any Cause
Time frame: up to one month after contrast exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32874376Stokfisz 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.
- Individual participant dataSharing planned: Yes. The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
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Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzenna Zielinska, MD PhD study chair
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning in people with Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Contrast Induced-Acute Kidney Injury (time frame: 48 to 72 hours after contrast exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.