Contrast-induced Acute Kidney InjuryPRINCESNCT07179874
Remote Ischemic Preconditioning to Prevent Contrast-Induced Kidney Injury in Diabetic Patients (PRINCES)
A study testing Remote Ischemic Preconditioning in people with Contrast-induced Acute Kidney Injury, run by Universidad de Murcia.
Trial summary
This study investigates whether remote ischemic preconditioning (RIPC)-a non-invasive technique involving brief cycles of blood flow restriction to the arm-can prevent contrast-induced nephropathy (CIN) in diabetic patients undergoing coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Acute Kidney Injury
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2015to 9 Jan 2017
- 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
- Patient diagnosed with diabetes mellitus.
- Age above 18 years.
- Admission to the ICU due to acute coronary syndrome.
- Indication for undergoing a coronary arteriography (either urgent or scheduled)
- Patients who received a coronary arteriography within the last 72 hours (if previously recruited, counted as new for randomization).
- Possibility to perform the RIPC maneuver without delaying the catheterization
Who cannot join
- Absence of diabetes mellitus.
- Pregnant women.
- Renal transplant recipients.
- Patients who underwent urological procedures or received intravenous contrast within the last 72 hours.
- Diagnosis of end-stage renal disease requiring hemodialysis.
- Participation in another clinical trial.
About this study
Official title: Effects of Remote Ischemic Preconditioning on Contrast-Induced Kidney Damage in Diabetic Patients: Link to Oxidative Stress
This study investigates whether remote ischemic preconditioning (RIPC)-a non-invasive technique involving brief cycles of blood flow restriction to the arm-can prevent contrast-induced nephropathy (CIN) in diabetic patients undergoing coronary angiography. Diabetes mellitus increases the risk of CIN due to heightened oxidative stress and disrupted protective cellular signaling.
While previous research suggests that RIPC may activate renal protective mechanisms, its efficacy in diabetic individuals remains controversial, as metabolic and neurovascular alterations may compromise its effect. This randomized trial aims to determine whether RIPC reduces oxidative kidney damage and improves renal outcomes in this high-risk population. The study will also explore the biological basis for potential variability in response, focusing on oxidative stress biomarkers and early kidney injury indicators.
Read the detailed description
This clinical trial explores a non-invasive method known as Remote Ischemic Preconditioning (RIPC) to prevent contrast-induced kidney damage in people with diabetes who are undergoing coronary catheterization. RIPC involves applying brief cycles of restricted blood flow to the arm using a pressure cuff before a medical procedure. Research suggests that RIPC may trigger protective biological responses in distant organs, such as the kidneys, by activating endogenous defense mechanisms including the antioxidant enzyme heme oxygenase-1 (HO-1), and modulation of inflammatory pathways.
The study focuses on a serious complication called Contrast-Induced Nephropathy (CIN)-an acute kidney injury that can occur in patients exposed to contrast dye during medical imaging. CIN is particularly common and severe among individuals with diabetes mellitus and impaired renal function. In this population, the incidence of CIN may reach up to 90%, leading to adverse clinical outcomes and increased healthcare costs.
One major mechanism implicated in CIN is oxidative stress, a state in which excess reactive oxygen species (ROS) overwhelm the body's antioxidant defenses. This imbalance is even more pronounced in diabetic kidneys, where chronic metabolic dysregulation and endothelial dysfunction contribute to heightened susceptibility.
Although early evidence pointed toward a protective role of RIPC against CIN, growing data suggest that its efficacy may be compromised in diabetic individuals. Diabetes-related impairments-including disrupted intracellular signaling, reduced humoral mediator release, autonomic dysfunction, and increased oxidative stress-could attenuate the protective cascade activated by RIPC. Furthermore, peripheral neuropathy, a common complication affecting up to 50% of diabetic patients, may interfere with the neural transmission necessary for systemic RIPC effects.
Nonetheless, clinical studies such as the RenPro Trial have reported preserved RIPC-mediated protection in diabetic populations undergoing contrast exposure. These divergent findings raise important questions about patient-specific factors-including glycemic control, pharmacotherapy, and comorbid conditions-that may modulate the efficacy of this intervention.
The present study was initially designed to evaluate the protective potential of RIPC in the diabetic population. However, from its inception, the trial also considered the hypothesis that protective mechanisms may be altered or suppressed in diabetes. As such, it aims not only to assess clinical outcomes, but also to explore biological indicators that might explain variability in response.
This randomized, parallel-group trial will be conducted in the intensive care unit (ICU) at Hospital General Universitario Santa Lucía. Participants will include adults with diabetes admitted for acute coronary syndrome and scheduled for coronary angiography. Subjects will be randomly assigned to:
- RIPC + hydration group
- Hydration-only control group All participants will receive standard intravenous fluid therapy before and after contrast administration. Those in the RIPC group will undergo four cycles of cuff-induced limb ischemia and reperfusion immediately prior to the procedure.
Biological samples (blood and urine) will be collected at baseline, 24h, 48h, and 72h after contrast exposure to evaluate:
- Traditional kidney function markers: serum creatinine
- Early kidney injury biomarkers: cystatin C.
- Oxidative stress markers: MDA, HO-1 (plasma, urine, and intracellular)
Secondary outcomes include:
- Duration of ICU and hospital stay
- In-hospital mortality
- Correlation between biomarker profiles and prognosis Laboratory analyses will include ELISA and Western blot techniques, while statistical modeling will assess predictive factors and treatment effects.
This study aims to clarify whether RIPC can offer a reproducible, low-cost strategy to prevent CIN in a high-risk diabetic population, and to deepen understanding of the cellular and systemic mechanisms underpinning renal protection under metabolic stress.
- Conditions
- Contrast-induced Acute Kidney Injury
- Being tested
- Remote Ischemic Preconditioning
- Keywords
- Remote Ischemic Preconditioning, Diabetes Mellitus, Heme Oxygenase-1
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
This intervention involves a non-invasive, mechanical stimulus applied to an upper limb with the goal of activating systemic protective pathways against contrast-induced nephropathy in diabetic patients. Unlike pharmacologic or device-based interventions, RIPC:
- Does not involve any drugs, biologics, or implants
- Is performed using a standard blood pressure cuff, inflated to 50 mmHg above systolic pressure, specifically designed to induce repetitive transient limb ischemia
- Consists of four alternating cycles of 5 minutes inflation followed by 5 minutes reperfusion
- Is applied 45 minutes before coronary catheterization, timed to optimize systemic renal protection prior to exposure to contrast media
- Targets activation of the heme oxygenase-1 (HO-1) enzymatic pathway, linking limb ischemia with antioxidant renal defense mechanisms Unlike interventions that rely solely on hydration or pharmacological antioxidants, this approach seeks to prime endogenous protective systems through is
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemyc preconditioning. | Experimental | Participants assigned to this arm received:
* Standard hydration therapy: intravenous infusion of 0.9% saline at 1 ml/kg/h for 12 hours before and after coronary catheterization
* Plus the RIPC procedure: four alternating cycles of upper-arm ischemia (inflating a blood pressure cuff 50 mmHg above systolic pressure for 5 minutes, followed by 5 minutes of reperfusion) performed approximately 45 minutes before catheterization This group was intended to assess the protective renal effects of RIPC in diabetic patients undergoing exposure to intravenous contrast media. Receives: Procedure: Remote Ischemic Preconditioning |
| Control Arm-NO RIPC | No intervention | Participants in the control arm receive standard care without remote ischemic preconditioning (RIPC). All patients undergo intravenous hydration as part of standard preventive measures prior to coronary catheterization. * Intervention: 0.9% saline solution administered intravenously at a rate of 1 ml/kg/hour * Timing: Initiated 12 hours before the procedure and maintained for 12 hours afterward * Additional Notes: No cuff inflation or ischemic maneuvers are performed. Patients do not receive sham stimulation or any form of simulated ischemia. This arm reflects usual clinical practice in patients undergoing catheterization who meet inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL from baseline within 72 hours after contrast exposure
- Metric: Absolute change in serum creatinine level (mg/dL)
- Time Frame: 24, 48, and 72 hours post-contrast administration
- Purpose: Evaluates the incidence and severity of contrast-induced nephropathy (CIN)
- Rationale: Creatinine is a key biomarker for acute kidney injury, particularly relevant in diabetic populations receiving iodinated contrast agents
Measured: Time Frame: 24, 48, and 72 hours post-contrast administration
Secondary outcomes (6)
- Changes in Heme Oxygenase-1 (HO-1) concentration in plasma .
Quantitative change in plasma levels of Heme Oxygenase-1 (HO-1) measured in nanograms per milliliter (ng/mL) using ELISA (ADI-960-071; commercial distributor: Enzo Diagnostics) before and after remote ischemic preconditioning (RIPC).
Measured: 24, 48, and 72 hours after contrast administration
Duration of ICU/Hospital Stay.
Total number of days spent in the ICU and hospital.
Measured: Up to 30 days post-ICU admission
Survival .
Survival will be assessed as all-cause mortality.
Measured: 6 weeks post-hospital discharge
Hospital Readmission Rate
Number of patients readmitted to the hospital within 6 weeks post-hospital discharge.
Measured: 6 weeks post-hospital discharge
Clinical Status
Assessment of the patient's clinical condition at discharge (e.g., stable, improved, deteriorated).
Measured: 6 weeks post-hospital discharge
Need for Dialysis
Number of patients requiring renal replacement therapy .
Measured: 6 weeks post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start25 Feb 2015
- Primary completion9 Jan 2017
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced Acute Kidney 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
- Parallel groups
- Model description
- Participants were randomized using block randomization with sealed opaque envelopes.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Santa Lucía
- Responsible party
- Principal investigator, Francisca Rodriguez Mulero, Universidad de Murcia
- Investigators
- FRANCISCA RODRIGUEZ, Ph.D, Principal investigator, University of Murcia-MURCIAMARIA DOLORES RODRIGUEZ, M.D. Ph.D., Principal investigator, Hospital Santa Lucía-CARTAGENA, MURCIAMARIA GALINDO MARTINEZ, M.D. Ph.D., Principal investigator, Hospital Santa Lucía-CARTAGENA, MURCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179874
- Sponsor's protocol ID
- Tl14-13 MGM
- Acronym
- PRINCES
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Description: Individual participant data (IPD) and related data dictionaries will be made available to qualified researchers upon reasonable request. The data sharing will be subject to restrictions, including the requirement for prior approval by all principal investigators involved in the study. Access will be granted only after review of the research proposal to ensure it aligns with ethical and scientific standards. Time Frame: Beginning 6 months after publication of the primary results; data available for up to 2 years. Access Criteria: Researchers must submit a detailed, methodologically sound proposal and sign a data use agreement that protects participant confidentiality. Access Mechanism: Data will be shared through a secure institutional repository or directly by the study sponsor upon approval.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Preconditioning on Contrast-Induced Kidney Damage in Diabetic Patients: Link to Oxidative Stress
- ClinicalTrials.gov ID
- NCT07179874
- Acronym / sponsor ID
- PRINCES / Tl14-13 MGM
- Conditions
- Contrast-induced Acute Kidney Injury
- Keywords
- Remote Ischemic Preconditioning, Diabetes Mellitus, Heme Oxygenase-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Collaborators
- Hospital General Universitario Santa Lucía
- Study start
- 25 Feb 2015 (actual)
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 18 Sep 2025 (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 investigates whether remote ischemic preconditioning (RIPC)-a non-invasive technique involving brief cycles of blood flow restriction to the arm-can prevent contrast-induced nephropathy (CIN) in diabetic patients undergoing coronary angiography. Diabetes mellitus increases the risk of CIN due to heightened oxidative stress and disrupted protective cellular signaling.
While previous research suggests that RIPC may activate renal protective mechanisms, its efficacy in diabetic individuals remains controversial, as metabolic and neurovascular alterations may compromise its effect. This randomized trial aims to determine whether RIPC reduces oxidative kidney damage and improves renal outcomes in this high-risk population. The study will also explore the biological basis for potential variability in response, focusing on oxidative stress biomarkers and early kidney injury indicators.
Detailed description
This clinical trial explores a non-invasive method known as Remote Ischemic Preconditioning (RIPC) to prevent contrast-induced kidney damage in people with diabetes who are undergoing coronary catheterization. RIPC involves applying brief cycles of restricted blood flow to the arm using a pressure cuff before a medical procedure. Research suggests that RIPC may trigger protective biological responses in distant organs, such as the kidneys, by activating endogenous defense mechanisms including the antioxidant enzyme heme oxygenase-1 (HO-1), and modulation of inflammatory pathways.
The study focuses on a serious complication called Contrast-Induced Nephropathy (CIN)-an acute kidney injury that can occur in patients exposed to contrast dye during medical imaging. CIN is particularly common and severe among individuals with diabetes mellitus and impaired renal function. In this population, the incidence of CIN may reach up to 90%, leading to adverse clinical outcomes and increased healthcare costs.
One major mechanism implicated in CIN is oxidative stress, a state in which excess reactive oxygen species (ROS) overwhelm the body's antioxidant defenses. This imbalance is even more pronounced in diabetic kidneys, where chronic metabolic dysregulation and endothelial dysfunction contribute to heightened susceptibility.
Although early evidence pointed toward a protective role of RIPC against CIN, growing data suggest that its efficacy may be compromised in diabetic individuals. Diabetes-related impairments-including disrupted intracellular signaling, reduced humoral mediator release, autonomic dysfunction, and increased oxidative stress-could attenuate the protective cascade activated by RIPC. Furthermore, peripheral neuropathy, a common complication affecting up to 50% of diabetic patients, may interfere with the neural transmission necessary for systemic RIPC effects.
Nonetheless, clinical studies such as the RenPro Trial have reported preserved RIPC-mediated protection in diabetic populations undergoing contrast exposure. These divergent findings raise important questions about patient-specific factors-including glycemic control, pharmacotherapy, and comorbid conditions-that may modulate the efficacy of this intervention.
The present study was initially designed to evaluate the protective potential of RIPC in the diabetic population. However, from its inception, the trial also considered the hypothesis that protective mechanisms may be altered or suppressed in diabetes. As such, it aims not only to assess clinical outcomes, but also to explore biological indicators that might explain variability in response.
This randomized, parallel-group trial will be conducted in the intensive care unit (ICU) at Hospital General Universitario Santa Lucía. Participants will include adults with diabetes admitted for acute coronary syndrome and scheduled for coronary angiography. Subjects will be randomly assigned to:
- RIPC + hydration group
- Hydration-only control group All participants will receive standard intravenous fluid therapy before and after contrast administration. Those in the RIPC group will undergo four cycles of cuff-induced limb ischemia and reperfusion immediately prior to the procedure.
Biological samples (blood and urine) will be collected at baseline, 24h, 48h, and 72h after contrast exposure to evaluate:
- Traditional kidney function markers: serum creatinine
- Early kidney injury biomarkers: cystatin C.
- Oxidative stress markers: MDA, HO-1 (plasma, urine, and intracellular)
Secondary outcomes include:
- Duration of ICU and hospital stay
- In-hospital mortality
- Correlation between biomarker profiles and prognosis Laboratory analyses will include ELISA and Western blot techniques, while statistical modeling will assess predictive factors and treatment effects.
This study aims to clarify whether RIPC can offer a reproducible, low-cost strategy to prevent CIN in a high-risk diabetic population, and to deepen understanding of the cellular and systemic mechanisms underpinning renal protection under metabolic stress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized using block randomization with sealed opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Remote ischemyc preconditioning. | Experimental | Procedure: Remote Ischemic PreconditioningParticipants assigned to this arm received: * Standard hydration therapy: intravenous infusion of 0.9% saline at 1 ml/kg/h for 12 hours before and after coronary catheterization * Plus the RIPC procedure: four alternating cycles of upper-arm ischemia (inflating a blood pressure cuff 50 mmHg above systolic pressure for 5 minutes, followed by 5 minutes of reperfusion) performed approximately 45 minutes before catheterization This group was intended to assess the protective renal effects of RIPC in diabetic patients undergoing exposure to intravenous contrast media. |
| Control Arm-NO RIPC | No intervention | –Participants in the control arm receive standard care without remote ischemic preconditioning (RIPC). All patients undergo intravenous hydration as part of standard preventive measures prior to coronary catheterization. * Intervention: 0.9% saline solution administered intravenously at a rate of 1 ml/kg/hour * Timing: Initiated 12 hours before the procedure and maintained for 12 hours afterward * Additional Notes: No cuff inflation or ischemic maneuvers are performed. Patients do not receive sham stimulation or any form of simulated ischemia. This arm reflects usual clinical practice in patients undergoing catheterization who meet inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient diagnosed with diabetes mellitus.
- Age above 18 years.
- Admission to the ICU due to acute coronary syndrome.
- Indication for undergoing a coronary arteriography (either urgent or scheduled)
- Patients who received a coronary arteriography within the last 72 hours (if previously recruited, counted as new for randomization).
Key exclusion criteria (6 listed)
- Absence of diabetes mellitus.
- Pregnant women.
- Renal transplant recipients.
- Patients who underwent urological procedures or received intravenous contrast within the last 72 hours.
- Diagnosis of end-stage renal disease requiring hemodialysis.
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 PreconditioningThis intervention involves a non-invasive, mechanical stimulus applied to an upper limb with the goal of activating systemic protective pathways against contrast-induced nephropathy in diabetic patients. Unlike pharmacologic or device-based interventions, RIPC: * Does not involve any drugs, biologics, or implants * Is performed using a standard blood pressure cuff, inflated to 50 mmHg above systolic pressure, specifically designed to induce repetitive transient limb ischemia * Consists of four alternating cycles of 5 minutes inflation followed by 5 minutes reperfusion * Is applied 45 minutes before coronary catheterization, timed to optimize systemic renal protection prior to exposure to contrast media * Targets activation of the heme oxygenase-1 (HO-1) enzymatic pathway, linking limb ischemia with antioxidant renal defense mechanisms Unlike interventions that rely solely on hydration or pharmacological antioxidants, this approach seeks to prime endogenous protective systems through is | Procedure or surgery | Remote ischemyc preconditioning. |
Primary outcome
Incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL from baseline within 72 hours after contrast exposure
Time frame: Time Frame: 24, 48, and 72 hours post-contrast administration
* Metric: Absolute change in serum creatinine level (mg/dL) * Time Frame: 24, 48, and 72 hours post-contrast administration * Purpose: Evaluates the incidence and severity of contrast-induced nephropathy (CIN) * Rationale: Creatinine is a key biomarker for acute kidney injury, particularly relevant in diabetic populations receiving iodinated contrast agents
6 secondary outcomes
- Changes in Heme Oxygenase-1 (HO-1) concentration in plasma .
Time frame: 24, 48, and 72 hours after contrast administration
Duration of ICU/Hospital Stay.
Time frame: Up to 30 days post-ICU admission
Survival .
Time frame: 6 weeks post-hospital discharge
Hospital Readmission Rate
Time frame: 6 weeks post-hospital discharge
Clinical Status
Time frame: 6 weeks post-hospital discharge
Need for Dialysis
Time frame: 6 weeks post-hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. Description: Individual participant data (IPD) and related data dictionaries will be made available to qualified researchers upon reasonable request. The data sharing will be subject to restrictions, including the requirement for prior approval by all principal investigators involved in the study. Access will be granted only after review of the research proposal to ensure it aligns with ethical and scientific standards. Time Frame: Beginning 6 months after publication of the primary results; data available for up to 2 years. Access Criteria: Researchers must submit a detailed, methodologically sound proposal and sign a data use agreement that protects participant confidentiality. Access Mechanism: Data will be shared through a secure institutional repository or directly by the study sponsor upon approval.
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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.
FRANCISCA RODRIGUEZ, Ph.D principal investigator
University of Murcia-MURCIA
MARIA DOLORES RODRIGUEZ, M.D. Ph.D. principal investigator
Hospital Santa Lucía-CARTAGENA, MURCIA
MARIA GALINDO MARTINEZ, M.D. Ph.D. principal investigator
Hospital Santa Lucía-CARTAGENA, MURCIA
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning in people with Contrast-induced Acute Kidney Injury, run by Universidad de Murcia.
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 6 inclusion and 6 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL from baseline within 72 hours after contrast exposure (time frame: Time Frame: 24, 48, and 72 hours post-contrast 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 22 Sep 2025.