Contrast Induced NephropathyNCT01144091
Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography
A study testing pentoxyphylline and pentoxiphylline in people with Contrast Induced Nephropathy and Diabetes Mellitus, run by Meir Medical Center.
Trial summary
The investigators will study 2 separate groups: Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous coronary intervention). Patients undergoing CT examination with contrast medium. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Contrast Induced Nephropathy, Diabetes Mellitus
- What is being tested?
- pentoxyphylline and pentoxiphylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiology patients:
- Hospitalization for ACS (acute coronary syndrome) with NSTEMI or Unstable Angina
- Diabetic patients (treated with insulin or oral hypoglycemic drugs) or patients with basal serum creatinine greater than 1.3mg/dl in females and 1.5 mg/dl in male patients.
- Informed consent
- Age between 18-75
- Radiology patients:
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- Radiology patients should be diabetic patients (treated with insulin or oral hypoglycemic drugs) or patients with basal serum creatinine of 1.3mg/dl in females and 1.5 mg/dl in male patients.
- Informed consent
- Age between 18-75
Who cannot join
None listed.
About this study
The investigators will study 2 separate groups:
- Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous coronary intervention).
- Patients undergoing CT examination with contrast medium. All patients will receive intravenous (I.V) hydration for 8-12h before and 36 to 48 h after angiography with 0.45% saline 100ml/h.
Read more
All patients will receive oral N-acetyl cysteine 1200 mg twice daily, a day before, on the day of the angiography and for another 48 hours.
In addition, patients will be assigned to receive oral pentoxyphylline (P group) or placebo (C - control group) tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and two days after angiography. Radio-contrast nephropathy is defined, in this study, as increase in serum ≥ 25 % of baseline after injection of the radio-contrast agent. Pentoxyfylline is an orally active haemorheological agent for the treatment of peripheral vascular disease, cerebrovascular disease and a number of other conditions involving a defective regional microcirculation. Pentoxyfylline acts primarily by increasing red blood cell deformability, by reducing blood viscosity and by decreasing the potential for platelet aggregation and thrombus formation (mechanism unclear). Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect, mechanisms considered to be important patho-physiological causes of contrast induced nephropathy.
Read the detailed description
Impairment of renal function following exposure to intravenous radio-graphic contrast materials is the third major cause of renal hospital acquired renal dysfunction. Renal dysfunction occurs most often in patients with chronic renal failure and or patients with diabetes mellitus and contributes to the morbidity and mortality. Previous research work proved that the use volume expansion with N-acetyl cysteine (NAC) is superior to volume expiation alone to prevent renal impairment due to radio-contrast5. NAC a potent anti oxidant may prevent CIN by stopping direct oxidative tissue damage and by improving renal hemodynamics.Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect.Preangiographic and the highest post-angiographic values of Creatinine and eGFR (estimated glomerular filtration rate) will be recorded. Levels of the biomarker Neutrophil - gelatinase - associated lipocalin (NGAL) will be tested randomly in 49 patients p as a biomarker for contrast induced nephropathy. Blood serology for NGAL will be drown from patients before the procedure and 2 hours after angiography.
- Conditions
- Contrast Induced Nephropathy, Diabetes Mellitus
- Being tested
- pentoxyphylline, placebo, pentoxiphylline
- Keywords
- diabetes mellitus, creatinin level, contrast induced nephropathy, prevention contrast induced nephropathy in high risk patients
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxyphyllineDrug
Also called Oxopurin, Trental, Pentoxifylline-Teva
pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.
placeboDrug
placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
pentoxiphyllineDrug
Also called terental, oxopurin, Pentoxifylline-Teva
pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.
placeboDrug
placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| pentoxyphylline cardio | Experimental | Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography Receives: Drug: pentoxyphylline |
| placebo cardio | Placebo comparator | Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography Receives: Drug: placebo |
| radiology pentoxyphylline | Experimental | Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast Receives: Drug: pentoxiphylline |
| radiology placebo | Placebo comparator | Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in high-risk patients undergoing angiography
The difference between preangiographic and postangiographic values (∆) for S.Cr and eGFR will be calculated and compared between groups. Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and levels of the biomarker Neutrophil - gelatinase - associated lipocalin (NGAL) will be tested randomly in 49 patients.contrast induced nephropathy.
Comparison of the ∆ between the preangiographic and postangiographic values for S.Cr and eGFR will be performed between the groups.
Measured: one year
Secondary outcomes (2)
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in diabetic patients undergoing angiography
Subgroup analysis will be performed for subgroups of patients with diabetes mellitus (DM)
Measured: one year
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in patients with elevated base line creatinin level > 2 undergoing angiography
Subgroup analysis will be performed for subgroups of patients high S.Cr levels before the procedure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startDec 2012
- Primary completionApr 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144091
- Sponsor's protocol ID
- MMC10059-2010
- Status last verified
- Sep 2012
- First submitted
- 7 Jun 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography
- ClinicalTrials.gov ID
- NCT01144091
- Acronym / sponsor ID
- MMC10059-2010
- Conditions
- Contrast Induced Nephropathy, Diabetes Mellitus
- Keywords
- diabetes mellitus, creatinin level, contrast induced nephropathy, prevention contrast induced nephropathy in high risk patients
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Jun 2010 (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 investigators will study 2 separate groups:
- Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous coronary intervention).
- Patients undergoing CT examination with contrast medium. All patients will receive intravenous (I.V) hydration for 8-12h before and 36 to 48 h after angiography with 0.45% saline 100ml/h.
All patients will receive oral N-acetyl cysteine 1200 mg twice daily, a day before, on the day of the angiography and for another 48 hours.
In addition, patients will be assigned to receive oral pentoxyphylline (P group) or placebo (C - control group) tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and two days after angiography. Radio-contrast nephropathy is defined, in this study, as increase in serum ≥ 25 % of baseline after injection of the radio-contrast agent. Pentoxyfylline is an orally active haemorheological agent for the treatment of peripheral vascular disease, cerebrovascular disease and a number of other conditions involving a defective regional microcirculation. Pentoxyfylline acts primarily by increasing red blood cell deformability, by reducing blood viscosity and by decreasing the potential for platelet aggregation and thrombus formation (mechanism unclear). Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect, mechanisms considered to be important patho-physiological causes of contrast induced nephropathy.
Detailed description
Impairment of renal function following exposure to intravenous radio-graphic contrast materials is the third major cause of renal hospital acquired renal dysfunction. Renal dysfunction occurs most often in patients with chronic renal failure and or patients with diabetes mellitus and contributes to the morbidity and mortality. Previous research work proved that the use volume expansion with N-acetyl cysteine (NAC) is superior to volume expiation alone to prevent renal impairment due to radio-contrast5. NAC a potent anti oxidant may prevent CIN by stopping direct oxidative tissue damage and by improving renal hemodynamics.Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect.Preangiographic and the highest post-angiographic values of Creatinine and eGFR (estimated glomerular filtration rate) will be recorded. Levels of the biomarker Neutrophil - gelatinase - associated lipocalin (NGAL) will be tested randomly in 49 patients p as a biomarker for contrast induced nephropathy. Blood serology for NGAL will be drown from patients before the procedure and 2 hours after angiography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pentoxyphylline cardio | Experimental | Drug: pentoxyphyllinePatients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography |
| placebo cardio | Placebo comparator | Drug: placeboPatients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography |
| radiology pentoxyphylline | Experimental | Drug: pentoxiphyllinePatients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast |
| radiology placebo | Placebo comparator | Drug: placeboPatients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hospitalization for ACS (acute coronary syndrome) with NSTEMI or Unstable Angina
- Diabetic patients (treated with insulin or oral hypoglycemic drugs) or patients with basal serum creatinine greater than 1.3mg/dl in females and 1.5 mg/dl in male patients.
- Informed consent
- Age between 18-75
- Radiology patients should be diabetic patients (treated with insulin or oral hypoglycemic drugs) or patients with basal serum creatinine of 1.3mg/dl in females and 1.5 mg/dl in male patients.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| pentoxyphyllineAlso: Oxopurin, Trental, Pentoxifylline-Tevapentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours. | Drug | pentoxyphylline cardio |
| placeboplacebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours. | Drug | placebo cardio |
| pentoxiphyllineAlso: terental, oxopurin, Pentoxifylline-Tevapentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours. | Drug | radiology pentoxyphylline |
| placeboplacebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours. | Drug | radiology placebo |
Primary outcome
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in high-risk patients undergoing angiography
Time frame: one year
The difference between preangiographic and postangiographic values (∆) for S.Cr and eGFR will be calculated and compared between groups. Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and levels of the biomarker Neutrophil - gelatinase - associated lipocalin (NGAL) will be tested randomly in 49 patients.contrast induced nephropathy. Comparison of the ∆ between the preangiographic and postangiographic values for S.Cr and eGFR will be performed between the groups.
2 secondary outcomes
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in diabetic patients undergoing angiography
Time frame: one year
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in patients with elevated base line creatinin level > 2 undergoing angiography
Time frame: one year
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 8 Apr 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing pentoxyphylline and pentoxiphylline in people with Contrast Induced Nephropathy and Diabetes Mellitus, run by Meir Medical Center.
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 9 inclusion and 0 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 8 Apr 2015. 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. Some participants in this study may receive a placebo. 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?
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in high-risk patients undergoing angiography (time frame: one year). 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 8 Apr 2015.