Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography

NCT01144091 | Withdrawn DMC

• 1 other identifier: MMC10059-2010
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Contrast Induced Nephropathy; Diabetes Mellitus

Keywords

diabetes mellitus; creatinin level; contrast induced nephropathy; prevention contrast induced nephropathy in high risk patients

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  one year

Study Arms (4)

pentoxyphylline cardio

EXPERIMENTAL

Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography

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

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

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

Drug: placebo

Interventions

pentoxyphylline DRUG

pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.

Also known as: Oxopurin, Trental, Pentoxifylline-Teva

pentoxyphylline cardio

placebo DRUG

placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.

placebo cardio

pentoxiphylline DRUG

pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.

Also known as: terental, oxopurin, Pentoxifylline-Teva

radiology pentoxyphylline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 15, 2010
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 8, 2015

Record last verified: 2012-09