Contrast-induced NephropathyPAIRNCT03136458
Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)
A study testing Ischemic preconditioning and Endovenous normal saline in people with Contrast-induced Nephropathy, run by Camilo Andrés Páez Angarita at 1 site in Colombia.
Trial summary
This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Nephropathy
- What is being tested?
- Ischemic preconditioning and Endovenous normal saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2016to 9 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized in general wards, emergency room or ambulatory consult.
- 18 years or older.
- Requires computerized tomography with endovenous contrast.
- Glomerular filtration rate between 30 - 60 mL/minute/1,73 m2.
- Patient accepts and signs informed consent.
Who cannot join
- Allergic to contrast media.
- Unable to accept or sign informed consent.
- Did not received endovenous saline before and/or after the contrast procedure.
- Peripheral arterial disease.
- Bilateral upper extremities lymph node dissection or any situation impending arterial pressure taking.
- Morbid obesity (body mass index 40 or more).
- Arterial systolic pressure greater than 175 mmHg.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Grupo Nefrología Fundación Valle del Lili
Cali, Valle del Cauca Department
About this study
Official title: Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)
This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not.
Read the detailed description
This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy, this preconditioning is administered through repeated insufflation of an arterial pressure cuff in one of the patient arms, which in theory liberates vasoactive mediators that prevents the ischemic damage to the kidneys secondary to contrast media. All of the patients will receive endovenous normal saline to prevent nephropathy, which is a common strategy in our institution. Half of the patients will receive remote ischemic preconditioning while the other half will only receive a dummy preconditioning intended to keep the double blind strategy of the trial.
The main endpoint will be to ascertain the incidence of contrast induced nephropathy in both arms of the study, as a way to evaluate the efficacy of this strategy.
- Conditions
- Contrast-induced Nephropathy
- Being tested
- Ischemic preconditioning, Endovenous normal saline
- Keywords
- contrast media, nephropathy, ischemic preconditioning
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioningProcedure or surgery
Also called remote ischemic preconditioning
Repeated remote ischemic preconditioning by arterial cuff insufflation.
Endovenous normal salineDrug
Also called normal saline 0,9%
endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.
| Study group | Role | What they receive |
|---|---|---|
| Real ischemic preconditioning | Experimental | Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 50 mmHg above the systolic arterial pressure of the patient. Receives: Procedure: Ischemic preconditioning; Drug: Endovenous normal saline |
| Dummy ischemic preconditioning | Active comparator | Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 10 mmHg above the diastolic arterial pressure of the patient. Receives: Drug: Endovenous normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy incidence
Increase in serum creatinine by 0,3 mg/dL compared to initial values.
Measured: 48 to 72 hours
Secondary outcomes (1)
Adverse effects to preconditioning.
Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.
Measured: 0 to 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Jan 2016
- Primary completion9 Oct 2018
- Study completion9 Oct 2018
Why it stopped: No resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced NephropathyStudies 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
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Andrés Páez Angarita
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Camilo Andrés Páez Angarita, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136458
- Sponsor's protocol ID
- ValledelLili
- Acronym
- PAIR
- Status last verified
- Oct 2018
- First submitted
- 24 Apr 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rudnick M, Feldman H. Contrast-induced nephropathy: what are the true clinical consequences? Clin J Am Soc Nephrol. 2008 Jan;3(1):263-72. doi: 10.2215/CJN.03690907.
PubMed 18178787Holscher B, Heitmeyer C, Fobker M, Breithardt G, Schaefer RM, Reinecke H. Predictors for contrast media-induced nephropathy and long-term survival: prospectively assessed data from the randomized controlled Dialysis-Versus-Diuresis (DVD) trial. Can J Cardiol. 2008 Nov;24(11):845-50. doi: 10.1016/s0828-282x(08)70193-4.
PubMed 18987758Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.
PubMed 15911862Bonventre JV. Limb ischemia protects against contrast-induced nephropathy. Circulation. 2012 Jul 24;126(4):384-7. doi: 10.1161/CIRCULATIONAHA.112.119701. Epub 2012 Jun 26. No abstract available.
PubMed 22735307Gassanov N, Nia AM, Caglayan E, Er F. Remote ischemic preconditioning and renoprotection: from myth to a novel therapeutic option? J Am Soc Nephrol. 2014 Feb;25(2):216-24. doi: 10.1681/ASN.2013070708. Epub 2013 Dec 5.
PubMed 24309187
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)
- ClinicalTrials.gov ID
- NCT03136458
- Acronym / sponsor ID
- PAIR / ValledelLili
- Conditions
- Contrast-induced Nephropathy
- Keywords
- contrast media, nephropathy, ischemic preconditioning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Camilo Andrés Páez AngaritaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 2 May 2017 (actual)
- 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 study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not.
Detailed description
This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy, this preconditioning is administered through repeated insufflation of an arterial pressure cuff in one of the patient arms, which in theory liberates vasoactive mediators that prevents the ischemic damage to the kidneys secondary to contrast media. All of the patients will receive endovenous normal saline to prevent nephropathy, which is a common strategy in our institution. Half of the patients will receive remote ischemic preconditioning while the other half will only receive a dummy preconditioning intended to keep the double blind strategy of the trial.
The main endpoint will be to ascertain the incidence of contrast induced nephropathy in both arms of the study, as a way to evaluate the efficacy of this strategy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Real ischemic preconditioning | Experimental | Procedure: Ischemic preconditioning, Drug: Endovenous normal salineInsufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 50 mmHg above the systolic arterial pressure of the patient. |
| Dummy ischemic preconditioning | Active comparator | Drug: Endovenous normal salineInsufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 10 mmHg above the diastolic arterial pressure of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized in general wards, emergency room or ambulatory consult.
- 18 years or older.
- Requires computerized tomography with endovenous contrast.
- Glomerular filtration rate between 30 - 60 mL/minute/1,73 m2.
- Patient accepts and signs informed consent.
Key exclusion criteria (7 listed)
- Allergic to contrast media.
- Unable to accept or sign informed consent.
- Did not received endovenous saline before and/or after the contrast procedure.
- Peripheral arterial disease.
- Bilateral upper extremities lymph node dissection or any situation impending arterial pressure taking.
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 |
|---|---|---|
| Ischemic preconditioningAlso: remote ischemic preconditioningRepeated remote ischemic preconditioning by arterial cuff insufflation. | Procedure or surgery | Real ischemic preconditioning |
| Endovenous normal salineAlso: normal saline 0,9%endovenous normal saline 1 mL per Kg per hour before and after contrast media injection. | Drug | Dummy ischemic preconditioning, Real ischemic preconditioning |
Primary outcome
Contrast induced nephropathy incidence
Time frame: 48 to 72 hours
Increase in serum creatinine by 0,3 mg/dL compared to initial values.
1 secondary outcome
Adverse effects to preconditioning.
Time frame: 0 to 72 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 18178787Rudnick M, Feldman H. Contrast-induced nephropathy: what are the true clinical consequences? Clin J Am Soc Nephrol. 2008 Jan;3(1):263-72. doi: 10.2215/CJN.03690907.
- Background: PubMed 18987758Holscher B, Heitmeyer C, Fobker M, Breithardt G, Schaefer RM, Reinecke H. Predictors for contrast media-induced nephropathy and long-term survival: prospectively assessed data from the randomized controlled Dialysis-Versus-Diuresis (DVD) trial. Can J Cardiol. 2008 Nov;24(11):845-50. doi: 10.1016/s0828-282x(08)70193-4.
- Background: PubMed 15911862Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.
- Background: PubMed 22735307Bonventre JV. Limb ischemia protects against contrast-induced nephropathy. Circulation. 2012 Jul 24;126(4):384-7. doi: 10.1161/CIRCULATIONAHA.112.119701. Epub 2012 Jun 26. No abstract available.
- Background: PubMed 24309187Gassanov N, Nia AM, Caglayan E, Er F. Remote ischemic preconditioning and renoprotection: from myth to a novel therapeutic option? J Am Soc Nephrol. 2014 Feb;25(2):216-24. doi: 10.1681/ASN.2013070708. Epub 2013 Dec 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic preconditioning and Endovenous normal saline in people with Contrast-induced Nephropathy, run by Camilo Andrés Páez Angarita at 1 site in Colombia.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 Oct 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 Colombia. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Contrast induced nephropathy incidence (time frame: 48 to 72 hours). 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 NCT03136458, which also lists 5 linked publications.
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 11 Oct 2018.