Contrast-induced NephropathyNCT03164681
Red Blood Cell Distribution Width as a Marker of Contrast Induced Nephropathy in Patients With Coronary Intervention
An observational study of Contrast-induced Nephropathy, run by Assiut University.
Trial summary
Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular administration of a contrast agent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Contrast-induced Nephropathy
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 30 Dec 2018
- Phase
- Observational
- 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
Study population: patients who underwent percutaneous coronary intervention
Who may be able to join
- Consecutive patients who underwent percutaneous coronary intervention either elective or emergency.
Who cannot join
- End stage renal disease with glomerular filtration rate less than 30 ml/1.73.
- Patient known allergy to contrast agents.
- Left ventricular ejection fraction below 30%.
- Presence of infection
- A recent history of contrast administration in the previous month.
- Patient known to have thyroid disease.
Show all 11Show fewer
- History of malignancy.
- Patient known to have Autoimmune disease.
- Decompensated liver cirrhosis
- Cardiogenic shock.
- Anemia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Red Blood Cell Distribution Width as a Predictor Marker of Contrast Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention
Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular administration of a contrast agent.
Read the detailed description
Contrast Induced Nephropathy has been introduced an important complication after coronary angiography and Percutaneous Coronary Intervention .
The development of Contrast Induced Nephropathy after Percutaneous Coronary Intervention is associated with poor clinical outcomes including prolonged hospitalization, increased costs, increased rates of end-stage renal failure, myocardial infarction, repeat revascularization, and short- and long-term mortality.
Contrast Induced Nephropathy follows decreased renal perfusion and administration of nephrotoxic medications as the third most common cause of renal insufficiency during hospitalization.
Patients with acute coronary syndrome have a 3-fold higher risk of developing Contrast Induced Nephropathy .Therefore ,predicting contrast nephropathy and initiating therapeutic preventive strategies are very important.
Red Blood Cell Distribution Width is a quantitive marker of the variability on size of erythrocyte.
It is a routine assay of Complete Blood Count that doesn't require an additional cost, that is calculated by dividing the standard deviation of the mean cell size by the Mean Corpuscular Volume of the red cells and multiplying by 100 to convert to a percentage.
Normal range of Red Blood Cell Distribution Width 11-16%. Increased Red Blood Cell Distribution Width means increased variability in red blood cell size owing to ineffective erythrocyte production, which is associated with indices of inflammation and pro-inflammatory cytokines such as interleukin-6 .
On the other hand, suggested mechanisms underlying Contrast Induced Nephropathy include cytotoxic effects, factors that affect renal hemodynamic, and regional hypoxia.
- Conditions
- Contrast-induced Nephropathy
- Keywords
- sheerly
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Induced Nephropathy
Percentage of patients with raised serum creatinine 25% or 0.5 mg/dl over baseline serum creatinine within 48 hour after contrast administration
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherly Boshra, Assiut University
- Investigators
- sherly boshra, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164681
- Sponsor's protocol ID
- RDWCIN
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehran R, Nikolsky E. Contrast-induced nephropathy: definition, epidemiology, and patients at risk. Kidney Int Suppl. 2006 Apr;(100):S11-5. doi: 10.1038/sj.ki.5000368.
PubMed 16612394Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
PubMed 15519007McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr 15;51(15):1419-28. doi: 10.1016/j.jacc.2007.12.035.
PubMed 18402894Bartholomew BA, Harjai KJ, Dukkipati S, Boura JA, Yerkey MW, Glazier S, Grines CL, O'Neill WW. Impact of nephropathy after percutaneous coronary intervention and a method for risk stratification. Am J Cardiol. 2004 Jun 15;93(12):1515-9. doi: 10.1016/j.amjcard.2004.03.008.
PubMed 15194023Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. doi: 10.1053/ajkd.2002.32766.
PubMed 11979336Tepel M, Aspelin P, Lameire N. Contrast-induced nephropathy: a clinical and evidence-based approach. Circulation. 2006 Apr 11;113(14):1799-806. doi: 10.1161/CIRCULATIONAHA.105.595090. No abstract available.
PubMed 16606801Seeliger E, Sendeski M, Rihal CS, Persson PB. Contrast-induced kidney injury: mechanisms, risk factors, and prevention. Eur Heart J. 2012 Aug;33(16):2007-15. doi: 10.1093/eurheartj/ehr494. Epub 2012 Jan 19.
PubMed 22267241
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Distribution Width as a Predictor Marker of Contrast Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03164681
- Acronym / sponsor ID
- RDWCIN
- Conditions
- Contrast-induced Nephropathy
- Keywords
- sheerly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 24 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.
Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular administration of a contrast agent.
Detailed description
Contrast Induced Nephropathy has been introduced an important complication after coronary angiography and Percutaneous Coronary Intervention .
The development of Contrast Induced Nephropathy after Percutaneous Coronary Intervention is associated with poor clinical outcomes including prolonged hospitalization, increased costs, increased rates of end-stage renal failure, myocardial infarction, repeat revascularization, and short- and long-term mortality.
Contrast Induced Nephropathy follows decreased renal perfusion and administration of nephrotoxic medications as the third most common cause of renal insufficiency during hospitalization.
Patients with acute coronary syndrome have a 3-fold higher risk of developing Contrast Induced Nephropathy .Therefore ,predicting contrast nephropathy and initiating therapeutic preventive strategies are very important.
Red Blood Cell Distribution Width is a quantitive marker of the variability on size of erythrocyte.
It is a routine assay of Complete Blood Count that doesn't require an additional cost, that is calculated by dividing the standard deviation of the mean cell size by the Mean Corpuscular Volume of the red cells and multiplying by 100 to convert to a percentage.
Normal range of Red Blood Cell Distribution Width 11-16%. Increased Red Blood Cell Distribution Width means increased variability in red blood cell size owing to ineffective erythrocyte production, which is associated with indices of inflammation and pro-inflammatory cytokines such as interleukin-6 .
On the other hand, suggested mechanisms underlying Contrast Induced Nephropathy include cytotoxic effects, factors that affect renal hemodynamic, and regional hypoxia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent percutaneous coronary intervention
Key inclusion criteria (1 listed)
- Consecutive patients who underwent percutaneous coronary intervention either elective or emergency.
Key exclusion criteria (11 listed)
- End stage renal disease with glomerular filtration rate less than 30 ml/1.73.
- Patient known allergy to contrast agents.
- Left ventricular ejection fraction below 30%.
- Presence of infection
- A recent history of contrast administration in the previous month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contrast Induced Nephropathy
Time frame: 48 Hours
Percentage of patients with raised serum creatinine 25% or 0.5 mg/dl over baseline serum creatinine within 48 hour after contrast administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Background: PubMed 16612394Mehran R, Nikolsky E. Contrast-induced nephropathy: definition, epidemiology, and patients at risk. Kidney Int Suppl. 2006 Apr;(100):S11-5. doi: 10.1038/sj.ki.5000368.
- Background: PubMed 15519007Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
- Background: PubMed 18402894McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr 15;51(15):1419-28. doi: 10.1016/j.jacc.2007.12.035.
- Background: PubMed 15194023Bartholomew BA, Harjai KJ, Dukkipati S, Boura JA, Yerkey MW, Glazier S, Grines CL, O'Neill WW. Impact of nephropathy after percutaneous coronary intervention and a method for risk stratification. Am J Cardiol. 2004 Jun 15;93(12):1515-9. doi: 10.1016/j.amjcard.2004.03.008.
- Background: PubMed 11979336Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. doi: 10.1053/ajkd.2002.32766.
- Results publication: PubMed 16606801Tepel M, Aspelin P, Lameire N. Contrast-induced nephropathy: a clinical and evidence-based approach. Circulation. 2006 Apr 11;113(14):1799-806. doi: 10.1161/CIRCULATIONAHA.105.595090. No abstract available.
- Results publication: PubMed 22267241Seeliger E, Sendeski M, Rihal CS, Persson PB. Contrast-induced kidney injury: mechanisms, risk factors, and prevention. Eur Heart J. 2012 Aug;33(16):2007-15. doi: 10.1093/eurheartj/ehr494. Epub 2012 Jan 19.
- 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.
sherly boshra principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast-induced Nephropathy, run by Assiut University.
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 1 inclusion and 11 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 24 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Tohamy, MD (01227370775, proftohammy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast Induced Nephropathy (time frame: 48 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 NCT03164681, which also lists 7 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 24 May 2017.