Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography
Information source: Meir Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contrast Induced Nephropathy; Diabetes Mellitus
Intervention: pentoxyphylline (Drug); placebo (Drug); pentoxiphylline (Drug); placebo (Drug)
Status: Not yet recruiting
Sponsored by: Meir Medical Center
Lotan Shilo, Md, Phone: 9727472141, Email: firstname.lastname@example.org
The investigators will study 2 separate groups:
- Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous
- 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.
Official title: Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in high-risk patients undergoing angiography
The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in diabetic patients undergoing angiography
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
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
1. Hospitalization for ACS (acute coronary syndrome) with NSTEMI or Unstable Angina
2. 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
3. Informed consent
4. Age between 18-75
1. 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.
2. Informed consent
3. Age between 18-75
Locations and Contacts
Lotan Shilo, Md, Phone: 9727472141, Email: email@example.comAdditional Information
Starting date: December 2012
Last updated: December 4, 2012