Contrast-Induced NephropathyPhase 2/3NCT02088502
Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy
A Phase 2/3 study testing N-acetylcysteine, Theophylline and 0.9% sodium chloride in people with Contrast-Induced Nephropathy, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. 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?
- N-acetylcysteine, Theophylline and 0.9% sodium chloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIran
- Study dates
- Sep 2013to Apr 2014
- 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
- adult patients
- candidate of elective coronary angiography or angioplasty
- at least moderate risk for contrast induced nephropathy
Who cannot join
- unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
- unstable serum creatinine
- unstable hemodynamic
- intravascular administration of contrast material in the past month
- using theophylline or N-acetylcysteine in the past month,
- known hypersensitivity to theophylline or N-acetylcysteine
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Chamran Hospital
Isfahan, Isfahan
Mortaza Arabmomeni, M.D., 09131268466, drmortezaarabmomeni@gmail.com
Mortaza Arabmomeni, M.D.
About this study
Official title: Comparative Evaluation of the Effect of Theophylline Plus N-acetylcysteine, Theophylline Alone, and N-acetylcysteine Alone in Preventing Contrast-induced Nephropathy in Patients With Moderate to High Risk Undergoing Coronary Angiographic Procedures
The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for elective coronary angiography or angioplasty and allocate them to each of the mentioned treatments from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.
- Conditions
- Contrast-Induced Nephropathy
- Being tested
- N-acetylcysteine, Theophylline, 0.9% sodium chloride
- Keywords
- Coronary Angiography, Side Effects, Contrast-Induced Nephropathy, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
TheophyllineDrug
0.9% sodium chlorideDrug
All patients are hydrated with 0.9% sodium chloride (1 mL/kg/hour) for 24 hours, 12 hours before operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg per hour.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | Patients in the N-acetylcysteine group receive 600 mg non-effervescent N-acetylcysteine tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material. Receives: Drug: N-acetylcysteine; Drug: 0.9% sodium chloride |
| Theophylline | Active comparator | Patients in the Theophylline group receive 200 mg Theophylline slow-release tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material. Receives: Drug: Theophylline; Drug: 0.9% sodium chloride |
| Theophylline plus N-acetylcysteine | Active comparator | Patients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material. Receives: Drug: N-acetylcysteine; Drug: Theophylline; Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma creatinine level
Plasma creatinine level is measured at baseline and after 48 hours of contrast injection. Increase in plasma creatinine level ≥ 0.5 mg/dL or ≥ 25% of the baseline creatinine after 48 hours of contrast injection will be considered contrast induced nephropathy.
Measured: up to 48h after contrast injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mortaza Arabmomeni, Isfahan University of Medical Sciences
- Investigators
- Mortaza Arabmomeni, M.D., Study director, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088502
- Sponsor's protocol ID
- 392300
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Albabtain MA, Almasood A, Alshurafah H, Alamri H, Tamim H. Efficacy of ascorbic acid, N-acetylcysteine, or combination of both on top of saline hydration versus saline hydration alone on prevention of contrast-Induced nephropathy: a prospective randomized study. J Interv Cardiol. 2013 Feb;26(1):90-6. doi: 10.1111/j.1540-8183.2012.00767.x. Epub 2012 Sep 20.
PubMed 22994682
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effect of Theophylline Plus N-acetylcysteine, Theophylline Alone, and N-acetylcysteine Alone in Preventing Contrast-induced Nephropathy in Patients With Moderate to High Risk Undergoing Coronary Angiographic Procedures
- ClinicalTrials.gov ID
- NCT02088502
- Acronym / sponsor ID
- 392300
- Conditions
- Contrast-Induced Nephropathy
- Keywords
- Coronary Angiography, Side Effects, Contrast-Induced Nephropathy, Prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (estimated)
- First posted
- 17 Mar 2014 (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.
The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for elective coronary angiography or angioplasty and allocate them to each of the mentioned treatments from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Drug: N-acetylcysteine, Drug: 0.9% sodium chloridePatients in the N-acetylcysteine group receive 600 mg non-effervescent N-acetylcysteine tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material. |
| Theophylline | Active comparator | Drug: Theophylline, Drug: 0.9% sodium chloridePatients in the Theophylline group receive 200 mg Theophylline slow-release tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material. |
| Theophylline plus N-acetylcysteine | Active comparator | Drug: N-acetylcysteine, Drug: Theophylline, Drug: 0.9% sodium chloridePatients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- candidate of elective coronary angiography or angioplasty
- at least moderate risk for contrast induced nephropathy
Key exclusion criteria (6 listed)
- unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
- unstable serum creatinine
- unstable hemodynamic
- intravascular administration of contrast material in the past month
- using theophylline or N-acetylcysteine in the past month,
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 |
|---|---|---|
| N-acetylcysteine | Drug | N-acetylcysteine, Theophylline plus N-acetylcysteine |
| Theophylline | Drug | Theophylline, Theophylline plus N-acetylcysteine |
| 0.9% sodium chlorideAll patients are hydrated with 0.9% sodium chloride (1 mL/kg/hour) for 24 hours, 12 hours before operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg per hour. | Drug | N-acetylcysteine, Theophylline, Theophylline plus N-acetylcysteine |
Primary outcome
Plasma creatinine level
Time frame: up to 48h after contrast injection
Plasma creatinine level is measured at baseline and after 48 hours of contrast injection. Increase in plasma creatinine level ≥ 0.5 mg/dL or ≥ 25% of the baseline creatinine after 48 hours of contrast injection will be considered contrast induced nephropathy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Background: PubMed 22994682Albabtain MA, Almasood A, Alshurafah H, Alamri H, Tamim H. Efficacy of ascorbic acid, N-acetylcysteine, or combination of both on top of saline hydration versus saline hydration alone on prevention of contrast-Induced nephropathy: a prospective randomized study. J Interv Cardiol. 2013 Feb;26(1):90-6. doi: 10.1111/j.1540-8183.2012.00767.x. Epub 2012 Sep 20.
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Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
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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.
Mortaza Arabmomeni, M.D. study director
Isfahan University of Medical Sciences
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 N-acetylcysteine, Theophylline and 0.9% sodium chloride in people with Contrast-Induced Nephropathy, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 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: status not confirmed, as of the sponsor's last update on 17 Mar 2014. 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 Iran. 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 Mortaza Arabmomeni, M.D. (09131268466, drmortezaarabmomeni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma creatinine level (time frame: up to 48h after contrast injection). 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 NCT02088502, which also lists 1 linked publication.
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 17 Mar 2014.