CA-AKI - Contrast-Associated Acute Kidney InjuryPhase 2/3NCT06286059
Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI
A Phase 2/3 study testing Phentolamine in people with CA-AKI - Contrast-Associated Acute Kidney Injury and Coronary Artery Disease, run by Helwan University at 1 site in Egypt.
Trial summary
To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Phentolamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2024to 31 Jan 2025
- Phase
- Phase 2/3
- 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
- Patients admitted to CCU with CAD.
- Patients underwent successful complex PCI defined as multivessel disease, more than two lesions, high coronary lesion complexity, chronic total occlusion, lesion length >30 mm, or bifurcation.
- Patients at high or very high risk for CA-AKI based on Mehran-2 CA-AKI Risk Score (Model 2).
Who cannot join
- Patients with end stage renal disease on regular dialysis.
- Patients with failed PCI revascularization.
- Patients presented with STEMI and underwent primary PCI.
- Patients presented with high risk NSTEMI defined as elevated cardiac enzymes with chest pain refractory to medications and/or dynamic ST changes.
- Patients presented with cardiogenic shock.
- Patients presented with any degree of heart block.
Show all 9Show fewer
- Patients with of history of asthma or hypersensitive for phentolamine.
- Patients on α-blockers, barbiturates or antipsychotic treatment.
- Patients intolerant to phentolamin with significant hemodynamic changes defined as >20% drop of systolic blood pressure (SBP) or >20% increase of heart rate (HR) after loading dose of phentolamine.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Badr university hospital
Badr, Cairo Governorate
Mohammed Soliman, MBBCH, +201032137563, Mohammed_Mostafa@med.helwan.edu.eg
About this study
Official title: Protective Efficacy of Phentolamine in Patients at High Risk of Contrast-Associated Acute Kidney Injury After Complex Percutaneous Coronary Intervention
To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI.
Read the detailed description
Coronary angiography is accepted as the gold standard diagnostic procedure in the management of coronary artery disease (CAD). It involves the visualization of the coronary arteries using contrast dye and dynamic X-ray imaging and allows for the identification of suitable lesions for percutaneous coronary intervention (PCI). PCI has more importance when performed as an emergency procedure during acute coronary syndromes (ACS) providing immediate relief of symptoms, preventing myocardial damage and reducing mortality rates despite its potential complications. These complications varies in its incidence including arrhythmias, coronary dissection, bleeding at the access site, allergy to contrast agent and kidney injury with varying risk on patient condition.
Contrast-associate acute kidney injury (CA-AKI), formerly termed contrast-induced nephropathy (CIN), is a significant complication of PCI and the third most common cause of renal failure in hospitalized patients. It is defined as a rise in creatinine of ≥ 50% of baseline or 0.3 mg/dL from the pre-contrast value within 48-72 hours of intravascular administration of a contrast medium, which is usually reversible acute kidney injury. The development of CA-AKI despite successful percutaneous coronary procedures is associated with prolonged hospitalization, an increase in health expenditure, and increased short and long-term mortality for most patients. Therefore, early risk prediction and management is crucial.
Over the past few decades, a number of risk scores have been introduced to predict contrast-associated acute kidney injury after PCI. The most commonly used is Mehran score that was introduced in 2004 for its simplicity and availability but it excluded patients with acute myocardial infarction. However, it recently updated with larger population and more emphasis on patient's ACS presentation and procedural features and reintroduced in 2021 as Mehran 2 CA-AKI Risk Score.
Exact pathophysiological mechanism of CA-AKI is not known and includes complex cascades of events. The most important elements of pathophysiological mechanism of CA-AKI seem to be the medullary hypoxia due to contrast-induced medullary vasoconstriction and direct renal tubular cytotoxicity, in addition to oxidative stress and the increase in blood and renal tubular viscosity which are complementary events that further exacerbates CA-AKI.
Several clinical interventions aimed to reduce the incidence of CA-AKI targeting various aspects of the pathophysiology including volume expansion with intravenous fluid, administration of N-acetylcysteine, sodium bicarbonate, vitamin E, statins and vasodilator agents with different protective efficacy but only few of them had been approved for clinical practice.
Vasodilators agents like nicorandil showed a statistically significant lower odds of developing CA-AKI with periprocedural hydration and the vasodilator agent nicorandil versus periprocedural hydration only (OR: 0.173). Also, a recent clinical trial has demonstrated encouraging results regarding the renoprotective effects of phentolamine in chronic coronary syndrome following PCI with odds ratio 0.04 of CA-AKI in phentolamine group in comparison to control group.
Phentolamine, a non-selective alpha-adrenergic antagonist, is primarily used for the treatment of conditions involving excessive sympathetic activity. While it is not a commonly used medication in the management of CAD, it used in various cardiovascular urgent conditions as in hypertensive crisis and in the treatment of cocaine-induced ACS which counteract the excessive sympathetic stimulation and reduce peripheral vascular resistance in conjunction with other treatments to alleviate symptoms and improve hemodynamics with less incidence of tachycardia associated with other vasodilators e.g. nitroglycerin.
This clinical trial will investigate the potential of phentolamine as a renoprotective agent following complex PCI by evaluating the impact of phentolamine on renal outcomes and its safety which may significantly impact clinical practice by guiding the use of phentolamine as an adjuvant therapy, ultimately improving patient outcomes and reducing the burden of CA-AKI in high-risk population.
- Conditions
- CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease, Acute Coronary Syndrome, Adrenergic Receptor Antagonist Adverse Reaction
- Being tested
- Phentolamine
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhentolamineDrug
Also called Rogitamine
In addition to the conventional management, patients will receive phentolamine (Rogitamine; Egypharma) infusion at a rate of 0.5 μgm/kg/min for the first 15 minutes after a bolus dose of 5 mg. If significant hemodynamic change occurred, the infusion then will be discontinued and the patient will be excluded. Otherwise, the dose will be uptitrated gradually 0.5-2 ugm/kg/min and the infusion will be continue for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients will receive conventional management including high dose atorvastatin and isotonic (0.9%) saline intravenous (IV) infusion at a rate of 1 ml/kg/hr for 12 hours or reduced to 0.5 ml/kg/hr if the patient's LVEF < 40% or overt heart failure. |
| Phentolamine group | Experimental | In addition to the conventional management, patients will receive phentolamine infusion. Receives: Drug: Phentolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CA-AKI
A rise in creatinine of ≥ 50% of baseline or 0.3 mg/dL from the pre-contrast value within 48-72 hours of intravascular administration of a contrast medium.
Measured: 3 days post-PCI
Secondary outcomes (10)
Peak of serum creatinine elevation
Maximum level of serum creatinine reached in patients who developed CA-AKI
Measured: 7 days
Duration of CA-AKI
Duration of CA-AKI in patients who developed CA-AKI
Measured: 14 days
Change in HR
Change in heart rate
Measured: 12 hours post-PCI
Change in SBP
Change in systolic blood pressure
Measured: 12 hours post-PCI
Change in DBP
Change in diastolic blood pressure
Measured: 12 hours post-PCI
Urine output
Urine output per hour post-PCI
Measured: 12 hours post-PCI
Rate of RRT
Rate of patients needed renal replacement therapy
Measured: 7 days
Rate of MACE
Composite rate of myocardial injury, non-fatal MI, non-fatal stroke, and all-cause mortality.
Measured: 30 days post-PCI
Rate of rehospitalization
Unplanned hospitalization during the first month post-PCI
Measured: 30 days post-PCI
Duration of hospitalization
Duration of hospitalization post-PCI until hospital discharge
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start7 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CA-AKI - Contrast-Associated 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Soliman Mostafa Mohammed, Helwan University
- Investigators
- Yasser Sadek, Professor, Study chair, Helwan UniversityArafa Gomaa, MD, Study director, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286059
- Sponsor's protocol ID
- Phentolamine for CA-AKI
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Master sheet of decoded data of the participants
Publications
Hamila MA, El Ghawaby H, Zaki M, Soliman M, Gabr K. Association of periprocedural phentolamine infusion with favorable outcome in patients with chronic kidney disease and chronic coronary syndrome undergoing coronary catheterization: a prospective randomized controlled pilot study. BMC Nephrol. 2022 Dec 31;23(1):416. doi: 10.1186/s12882-022-03050-9.
PubMed 36585656Kelesoglu S, Yilmaz Y, Elcik D, Cetinkaya Z, Inanc MT, Dogan A, Oguzhan A, Kalay N. Systemic Immune Inflammation Index: A Novel Predictor of Contrast-Induced Nephropathy in Patients With Non-ST Segment Elevation Myocardial Infarction. Angiology. 2021 Oct;72(9):889-895. doi: 10.1177/00033197211007738. Epub 2021 Apr 8.
PubMed 33827291Lu Y, Wang Y, Zhou B. Predicting long-term prognosis after percutaneous coronary intervention in patients with acute coronary syndromes: a prospective nested case-control analysis for county-level health services. Front Cardiovasc Med. 2023 Dec 4;10:1297527. doi: 10.3389/fcvm.2023.1297527. eCollection 2023.
PubMed 38111892Mehran R, Owen R, Chiarito M, Baber U, Sartori S, Cao D, Nicolas J, Pivato CA, Nardin M, Krishnan P, Kini A, Sharma S, Pocock S, Dangas G. A contemporary simple risk score for prediction of contrast-associated acute kidney injury after percutaneous coronary intervention: derivation and validation from an observational registry. Lancet. 2021 Nov 27;398(10315):1974-1983. doi: 10.1016/S0140-6736(21)02326-6. Epub 2021 Nov 15.
PubMed 34793743Ozkok S, Ozkok A. Contrast-induced acute kidney injury: A review of practical points. World J Nephrol. 2017 May 6;6(3):86-99. doi: 10.5527/wjn.v6.i3.86.
PubMed 28540198Walker H, Guthrie GD, Lambourg E, Traill P, Zealley I, Plumb A, Bell S. Systematic review and meta-analysis of prophylaxis use with intravenous contrast exposure to prevent contrast-induced nephropathy. Eur J Radiol. 2022 Aug;153:110368. doi: 10.1016/j.ejrad.2022.110368. Epub 2022 May 23.
PubMed 35636024
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Efficacy of Phentolamine in Patients at High Risk of Contrast-Associated Acute Kidney Injury After Complex Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06286059
- Acronym / sponsor ID
- Phentolamine for CA-AKI
- Conditions
- CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease, Acute Coronary Syndrome, Adrenergic Receptor Antagonist Adverse Reaction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 29 Feb 2024 (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.
To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI.
Detailed description
Coronary angiography is accepted as the gold standard diagnostic procedure in the management of coronary artery disease (CAD). It involves the visualization of the coronary arteries using contrast dye and dynamic X-ray imaging and allows for the identification of suitable lesions for percutaneous coronary intervention (PCI). PCI has more importance when performed as an emergency procedure during acute coronary syndromes (ACS) providing immediate relief of symptoms, preventing myocardial damage and reducing mortality rates despite its potential complications. These complications varies in its incidence including arrhythmias, coronary dissection, bleeding at the access site, allergy to contrast agent and kidney injury with varying risk on patient condition.
Contrast-associate acute kidney injury (CA-AKI), formerly termed contrast-induced nephropathy (CIN), is a significant complication of PCI and the third most common cause of renal failure in hospitalized patients. It is defined as a rise in creatinine of ≥ 50% of baseline or 0.3 mg/dL from the pre-contrast value within 48-72 hours of intravascular administration of a contrast medium, which is usually reversible acute kidney injury. The development of CA-AKI despite successful percutaneous coronary procedures is associated with prolonged hospitalization, an increase in health expenditure, and increased short and long-term mortality for most patients. Therefore, early risk prediction and management is crucial.
Over the past few decades, a number of risk scores have been introduced to predict contrast-associated acute kidney injury after PCI. The most commonly used is Mehran score that was introduced in 2004 for its simplicity and availability but it excluded patients with acute myocardial infarction. However, it recently updated with larger population and more emphasis on patient's ACS presentation and procedural features and reintroduced in 2021 as Mehran 2 CA-AKI Risk Score.
Exact pathophysiological mechanism of CA-AKI is not known and includes complex cascades of events. The most important elements of pathophysiological mechanism of CA-AKI seem to be the medullary hypoxia due to contrast-induced medullary vasoconstriction and direct renal tubular cytotoxicity, in addition to oxidative stress and the increase in blood and renal tubular viscosity which are complementary events that further exacerbates CA-AKI.
Several clinical interventions aimed to reduce the incidence of CA-AKI targeting various aspects of the pathophysiology including volume expansion with intravenous fluid, administration of N-acetylcysteine, sodium bicarbonate, vitamin E, statins and vasodilator agents with different protective efficacy but only few of them had been approved for clinical practice.
Vasodilators agents like nicorandil showed a statistically significant lower odds of developing CA-AKI with periprocedural hydration and the vasodilator agent nicorandil versus periprocedural hydration only (OR: 0.173). Also, a recent clinical trial has demonstrated encouraging results regarding the renoprotective effects of phentolamine in chronic coronary syndrome following PCI with odds ratio 0.04 of CA-AKI in phentolamine group in comparison to control group.
Phentolamine, a non-selective alpha-adrenergic antagonist, is primarily used for the treatment of conditions involving excessive sympathetic activity. While it is not a commonly used medication in the management of CAD, it used in various cardiovascular urgent conditions as in hypertensive crisis and in the treatment of cocaine-induced ACS which counteract the excessive sympathetic stimulation and reduce peripheral vascular resistance in conjunction with other treatments to alleviate symptoms and improve hemodynamics with less incidence of tachycardia associated with other vasodilators e.g. nitroglycerin.
This clinical trial will investigate the potential of phentolamine as a renoprotective agent following complex PCI by evaluating the impact of phentolamine on renal outcomes and its safety which may significantly impact clinical practice by guiding the use of phentolamine as an adjuvant therapy, ultimately improving patient outcomes and reducing the burden of CA-AKI in high-risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients will receive conventional management including high dose atorvastatin and isotonic (0.9%) saline intravenous (IV) infusion at a rate of 1 ml/kg/hr for 12 hours or reduced to 0.5 ml/kg/hr if the patient's LVEF < 40% or overt heart failure. |
| Phentolamine group | Experimental | Drug: PhentolamineIn addition to the conventional management, patients will receive phentolamine infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to CCU with CAD.
- Patients underwent successful complex PCI defined as multivessel disease, more than two lesions, high coronary lesion complexity, chronic total occlusion, lesion length >30 mm, or bifurcation.
- Patients at high or very high risk for CA-AKI based on Mehran-2 CA-AKI Risk Score (Model 2).
Key exclusion criteria (9 listed)
- Patients with end stage renal disease on regular dialysis.
- Patients with failed PCI revascularization.
- Patients presented with STEMI and underwent primary PCI.
- Patients presented with high risk NSTEMI defined as elevated cardiac enzymes with chest pain refractory to medications and/or dynamic ST changes.
- Patients presented with cardiogenic shock.
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 |
|---|---|---|
| PhentolamineAlso: RogitamineIn addition to the conventional management, patients will receive phentolamine (Rogitamine; Egypharma) infusion at a rate of 0.5 μgm/kg/min for the first 15 minutes after a bolus dose of 5 mg. If significant hemodynamic change occurred, the infusion then will be discontinued and the patient will be excluded. Otherwise, the dose will be uptitrated gradually 0.5-2 ugm/kg/min and the infusion will be continue for 12 hours. | Drug | Phentolamine group |
Primary outcome
Rate of CA-AKI
Time frame: 3 days post-PCI
A rise in creatinine of ≥ 50% of baseline or 0.3 mg/dL from the pre-contrast value within 48-72 hours of intravascular administration of a contrast medium.
10 secondary outcomes
Peak of serum creatinine elevation
Time frame: 7 days
Duration of CA-AKI
Time frame: 14 days
Change in HR
Time frame: 12 hours post-PCI
Change in SBP
Time frame: 12 hours post-PCI
Change in DBP
Time frame: 12 hours post-PCI
Urine output
Time frame: 12 hours post-PCI
Rate of RRT
Time frame: 7 days
Rate of MACE
Time frame: 30 days post-PCI
Rate of rehospitalization
Time frame: 30 days post-PCI
Duration of hospitalization
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 36585656Hamila MA, El Ghawaby H, Zaki M, Soliman M, Gabr K. Association of periprocedural phentolamine infusion with favorable outcome in patients with chronic kidney disease and chronic coronary syndrome undergoing coronary catheterization: a prospective randomized controlled pilot study. BMC Nephrol. 2022 Dec 31;23(1):416. doi: 10.1186/s12882-022-03050-9.
- Background: PubMed 33827291Kelesoglu S, Yilmaz Y, Elcik D, Cetinkaya Z, Inanc MT, Dogan A, Oguzhan A, Kalay N. Systemic Immune Inflammation Index: A Novel Predictor of Contrast-Induced Nephropathy in Patients With Non-ST Segment Elevation Myocardial Infarction. Angiology. 2021 Oct;72(9):889-895. doi: 10.1177/00033197211007738. Epub 2021 Apr 8.
- Background: PubMed 38111892Lu Y, Wang Y, Zhou B. Predicting long-term prognosis after percutaneous coronary intervention in patients with acute coronary syndromes: a prospective nested case-control analysis for county-level health services. Front Cardiovasc Med. 2023 Dec 4;10:1297527. doi: 10.3389/fcvm.2023.1297527. eCollection 2023.
- Background: PubMed 34793743Mehran R, Owen R, Chiarito M, Baber U, Sartori S, Cao D, Nicolas J, Pivato CA, Nardin M, Krishnan P, Kini A, Sharma S, Pocock S, Dangas G. A contemporary simple risk score for prediction of contrast-associated acute kidney injury after percutaneous coronary intervention: derivation and validation from an observational registry. Lancet. 2021 Nov 27;398(10315):1974-1983. doi: 10.1016/S0140-6736(21)02326-6. Epub 2021 Nov 15.
- Background: PubMed 28540198Ozkok S, Ozkok A. Contrast-induced acute kidney injury: A review of practical points. World J Nephrol. 2017 May 6;6(3):86-99. doi: 10.5527/wjn.v6.i3.86.
- Background: PubMed 35636024Walker H, Guthrie GD, Lambourg E, Traill P, Zealley I, Plumb A, Bell S. Systematic review and meta-analysis of prophylaxis use with intravenous contrast exposure to prevent contrast-induced nephropathy. Eur J Radiol. 2022 Aug;153:110368. doi: 10.1016/j.ejrad.2022.110368. Epub 2022 May 23.
- Individual participant dataSharing planned: Yes. Master sheet of decoded data of the participants
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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.
Yasser Sadek, Professor study chair
Helwan University
Arafa Gomaa, MD study director
Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Phentolamine in people with CA-AKI - Contrast-Associated Acute Kidney Injury and Coronary Artery Disease, run by Helwan University at 1 site in Egypt.
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 18 Mar 2024. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohammed Soliman (+201032137563, Mohammed_Mostafa@med.helwan.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CA-AKI (time frame: 3 days post-PCI). 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 NCT06286059, which also lists 6 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 18 Mar 2024.