Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography

NCT ID: NCT01144091

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

pentoxyphylline cardio

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

Group Type: EXPERIMENTAL

pentoxyphylline

Intervention Type: 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.

placebo cardio

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

radiology pentoxyphylline

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

Group Type: EXPERIMENTAL

pentoxiphylline

Intervention Type: 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.

radiology placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

placebo

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

Intervention Type: 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.

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

Oxopurin; Trental; Pentoxifylline-Teva; terental; oxopurin; Pentoxifylline-Teva

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MMC10059-2010

Identifier Type: -

Identifier Source: org_study_id