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Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography

Primary Purpose

Contrast Induced Nephropathy, Diabetes Mellitus

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pentoxyphylline
placebo
pentoxiphylline
placebo
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring diabetes mellitus, creatinin level, contrast induced nephropathy, prevention contrast induced nephropathy in high risk patients

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    pentoxyphylline cardio

    placebo cardio

    radiology pentoxyphylline

    radiology placebo

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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)
    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

    Full Information

    First Posted
    June 7, 2010
    Last Updated
    April 7, 2015
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01144091
    Brief Title
    Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography
    Official Title
    Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    April 2013 (Anticipated)
    Study Completion Date
    December 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Contrast Induced Nephropathy, Diabetes Mellitus
    Keywords
    diabetes mellitus, creatinin level, contrast induced nephropathy, prevention contrast induced nephropathy in high risk patients

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pentoxyphylline cardio
    Arm Type
    Experimental
    Arm Description
    Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography
    Arm Title
    placebo cardio
    Arm Type
    Placebo Comparator
    Arm Description
    Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo coronary angiography
    Arm Title
    radiology pentoxyphylline
    Arm Type
    Experimental
    Arm Description
    Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast
    Arm Title
    radiology placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients with chronic renal failure (CRF) and/or diabetes mellitus (DM) who are about to go to undergo computed tomography with contrast
    Intervention Type
    Drug
    Intervention Name(s)
    pentoxyphylline
    Other Intervention Name(s)
    Oxopurin, Trental, Pentoxifylline-Teva
    Intervention Description
    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
    Intervention Name(s)
    placebo
    Intervention Description
    placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    pentoxiphylline
    Other Intervention Name(s)
    terental, oxopurin, Pentoxifylline-Teva
    Intervention Description
    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
    Intervention Name(s)
    placebo
    Intervention Description
    placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
    Primary Outcome Measure Information:
    Title
    The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in high-risk patients undergoing angiography
    Description
    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.
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    The purpose of the study is to examine the potential renal protective effect of pentoxyphylline in diabetic patients undergoing angiography
    Description
    Subgroup analysis will be performed for subgroups of patients with diabetes mellitus (DM)
    Time Frame
    one year
    Title
    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
    Description
    Subgroup analysis will be performed for subgroups of patients high S.Cr levels before the procedure
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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

    12. IPD Sharing Statement

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