Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01144091
First received: June 7, 2010
Last updated: December 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Contrast Induced Nephropathy
Diabetes Mellitus
Drug: pentoxyphylline
Drug: placebo
Drug: pentoxiphylline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in diabetic patients undergoing angiography [ Time Frame: one year ] [ Designated as safety issue: No ]
    Subgroup analysis will be performed for subgroups of patients with diabetes mellitus (DM)

  • 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 ] [ Designated as safety issue: No ]
    Subgroup analysis will be performed for subgroups of patients high S.Cr levels before the procedure


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pentoxyphylline cardio
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography
Drug: pentoxyphylline
pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.
Other Names:
  • Oxopurin
  • Trental
  • Pentoxifylline-Teva
Placebo Comparator: placebo cardio
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography
Drug: placebo
placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
Experimental: radiology pentoxyphylline
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast
Drug: pentoxiphylline
pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.
Other Names:
  • terental
  • oxopurin
  • Pentoxifylline-Teva
Placebo Comparator: radiology placebo
Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast
Drug: placebo
placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cardiology patients:

  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 patients.
  3. Informed consent
  4. Age between 18-75

Radiology patients:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144091

Contacts
Contact: Lotan Shilo, Md 9727472141 lotansh@post.tau.ac.il

Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01144091     History of Changes
Other Study ID Numbers: MMC10059-2010
Study First Received: June 7, 2010
Last Updated: December 4, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
diabetes mellitus
creatinin level
contrast induced nephropathy
prevention contrast induced nephropathy in high risk patients

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Pentoxifylline
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014