Ischemic Reperfusion InjuryNCT02729155
Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy
A study testing RIPre and RIPost in people with Ischemic Reperfusion Injury, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Reperfusion Injury
- What is being tested?
- RIPre and RIPost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 596 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient have indication for coronary angiography or angioplasty.
- Impaired renal function with reduced eGFR < 60 ml/min/1.73 m2 by CKD-EPI equation.
- Written informed consent.
Who cannot join
- History of contrast allergy.
- The patient had end-stage renal failure with the need for hemodialysis.
- The patient take medications that affect the kidneys function within 48 hours before study.
- The patient had acute kidney injury from any cause.
- The patient was received contrast media within 2 weeks before study.
- The patient had cardiac arrest or shock.
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- The patient had peripheral arterial disease (PAD)
- Pregnancy
- Refused to study
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Internal Medicine
Bangkok, 10400
Nakarin Sansanayudh, MD,PhD, +6623547600 ext. 93827, dr_nakarin@hotmail.com
Pawit Pipatwattanakul, MD, +6613728821, pa_wit@hotmail.com
About this study
Official title: Efficacy of Single-cycle Remote Ischemic Pre/Post-conditioning, for Prevention of Contrast-induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Coronary Angiography or Coronary Angioplasty
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty
Read the detailed description
randomized controlled trial
- Conditions
- Ischemic Reperfusion Injury
- Being tested
- RIPre, RIPost, Sham-Pre, Sham-Post
- Keywords
- Ischemic Preconditioning, Postconditioning, Angioplasty, Angiography, Contrast-Induced Nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPreProcedure or surgery
Preconditioning 200 mmHg x 5 minutes before procedure
RIPostProcedure or surgery
Postconditioning 200 mmHg x 5 minutes after procedure
Sham-PreProcedure or surgery
Sham 10 mmHg x 5 minutes before procedure
Sham-PostProcedure or surgery
Sham 10 mmHg x 5 minutes after procedure
| Study group | Role | What they receive |
|---|---|---|
| RIPre + RIPost | Experimental | Intervention: RIPre 200 mmHg + RIPost 200 mmHg Receives: Procedure: RIPre; Procedure: RIPost |
| RIPre + Sham | Experimental | Intervention: RIPre 200 mmHg + Sham 10 mmHg Receives: Procedure: RIPre; Procedure: Sham-Post |
| Sham + RIPost | Experimental | Intervention: Sham 10 mmHg + RIPost 200 mmHg Receives: Procedure: RIPost; Procedure: Sham-Pre |
| Sham + Sham | Sham comparator | Intervention: Sham 10 mmHg + Sham 10 mmHg Receives: Procedure: Sham-Pre; Procedure: Sham-Post |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
Measured: Within a period of 24 hours after contrast medium administration
Secondary outcomes (7)
Change in sCr and eGFR from baseline
Measured: Within a period of 24 hours after contrast medium administration
Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Measured: Within a period of 6 months after contrast medium administration
Incidence(%) of CI-AKI in differrent subgroups of patient characteristics
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value.
Measured: Within a period of 24 hours after contrast medium administration
Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
Measured: Within a period of 24 hours after contrast medium administration
Incidence(%) of MACCE in differrent subgroups of patient characteristics
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Measured: Within a period of 6 months after contrast medium administration
Incidence(%) of MACCE in patients with vs without RIPre and RIPost
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Measured: Within a period of 6 months after contrast medium administration
Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value within a period of 24 hours after contrast medium administration
Measured: Within a period of 6 months after contrast medium administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Reperfusion InjuryStudies 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
- Investigators
- Nakarin Sansanayudh, MD,PhD, Principal investigator, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729155
- Sponsor's protocol ID
- PMK-SCRIP-CIN
- Status last verified
- Aug 2018
- First submitted
- 31 Mar 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single-cycle Remote Ischemic Pre/Post-conditioning, for Prevention of Contrast-induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Coronary Angiography or Coronary Angioplasty
- ClinicalTrials.gov ID
- NCT02729155
- Acronym / sponsor ID
- PMK-SCRIP-CIN
- Conditions
- Ischemic Reperfusion Injury
- Keywords
- Ischemic Preconditioning, Postconditioning, Angioplasty, Angiography, Contrast-Induced Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 596 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty
Detailed description
randomized controlled trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RIPre + RIPost | Experimental | Procedure: RIPre, Procedure: RIPostIntervention: RIPre 200 mmHg + RIPost 200 mmHg |
| RIPre + Sham | Experimental | Procedure: RIPre, Procedure: Sham-PostIntervention: RIPre 200 mmHg + Sham 10 mmHg |
| Sham + RIPost | Experimental | Procedure: RIPost, Procedure: Sham-PreIntervention: Sham 10 mmHg + RIPost 200 mmHg |
| Sham + Sham | Sham comparator | Procedure: Sham-Pre, Procedure: Sham-PostIntervention: Sham 10 mmHg + Sham 10 mmHg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient have indication for coronary angiography or angioplasty.
- Impaired renal function with reduced eGFR < 60 ml/min/1.73 m2 by CKD-EPI equation.
- Written informed consent.
Key exclusion criteria (9 listed)
- History of contrast allergy.
- The patient had end-stage renal failure with the need for hemodialysis.
- The patient take medications that affect the kidneys function within 48 hours before study.
- The patient had acute kidney injury from any cause.
- The patient was received contrast media within 2 weeks before study.
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 |
|---|---|---|
| RIPrePreconditioning 200 mmHg x 5 minutes before procedure | Procedure or surgery | RIPre + RIPost, RIPre + Sham |
| RIPostPostconditioning 200 mmHg x 5 minutes after procedure | Procedure or surgery | RIPre + RIPost, Sham + RIPost |
| Sham-PreSham 10 mmHg x 5 minutes before procedure | Procedure or surgery | Sham + RIPost, Sham + Sham |
| Sham-PostSham 10 mmHg x 5 minutes after procedure | Procedure or surgery | RIPre + Sham, Sham + Sham |
Primary outcome
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
Time frame: Within a period of 24 hours after contrast medium administration
7 secondary outcomes
Change in sCr and eGFR from baseline
Time frame: Within a period of 24 hours after contrast medium administration
Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group
Time frame: Within a period of 6 months after contrast medium administration
Incidence(%) of CI-AKI in differrent subgroups of patient characteristics
Time frame: Within a period of 24 hours after contrast medium administration
Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost
Time frame: Within a period of 24 hours after contrast medium administration
Incidence(%) of MACCE in differrent subgroups of patient characteristics
Time frame: Within a period of 6 months after contrast medium administration
Incidence(%) of MACCE in patients with vs without RIPre and RIPost
Time frame: Within a period of 6 months after contrast medium administration
Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI
Time frame: Within a period of 6 months after contrast medium administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: Yes
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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.
Nakarin Sansanayudh, MD,PhD principal investigator
Phramongkutklao College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPre and RIPost in people with Ischemic Reperfusion Injury, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 9 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: status not confirmed, as of the sponsor's last update on 31 Aug 2018. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nakarin Sansanayudh, MD,PhD (+6627639300 ext. 93807, dr_nakarin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value (time frame: Within a period of 24 hours after contrast medium administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2018.