Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy
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Purpose
Acute renal failure induced by radiographic contrast agents is a known complication of coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced nephropathy.
The aim of the current study is to investigate the effect of normobaric hyperoxygenation therapy on renal functions in patients at high risk for CIN undergoing coronary angiography.
The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated congestive heart failure, hemodynamic instability, known sensitivity to contrast media and patients who had been exposed to contrast media during the last 3 months will be excluded. Patients with oxygen blood saturation of less than 94% at room air will also be excluded from the study.
Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask (treated group) or breath room air (control group) for duration of 4 hours starting at the beginning of the angiographic procedure.
All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany).
All patients will be hospitalized 1 day before and at least 24 hours following angiography. Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48 hours after coronary angiography. Urine sample will be taken 24 hours before angiography and 6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to Isoprostanes and NO will be evaluated.
| Condition | Intervention |
|---|---|
|
Nephropathy |
Drug: 100% oxigen Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy. |
- contrast induced nephropathy [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Nitric Oxide in urine sample [ Time Frame: day -1, and 6,24,48 hours after exposure ] [ Designated as safety issue: No ]
- urinary isoprostanes [ Time Frame: day -1, and 6,24,48 hours after exposure ] [ Designated as safety issue: No ]
- blood urea and creatinin [ Time Frame: day -1, and 6,24,48 hours after exposure ] [ Designated as safety issue: No ]
- cystatin-C [ Time Frame: day -1, and 6,24,48 hours after exposure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 100% oxigen
patients will recive 100% oxigen in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
|
Drug: 100% oxigen
patients will recive 100% oxigen in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
|
|
Placebo Comparator: placebo
patients will recive 21% oxigen (room air) in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
|
Drug: placebo
patients will recive 21% oxigen (room air) in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- elective coronary angiography
- estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2
- inform consent
Exclusion Criteria:
- acute renal failure
- acute myocardial infarction
- noncompensated congestive heart failure
- hemodynamic instability
- known sensitivity to contrast media
- patients who had been exposed to contrast media during the last 3 months
- Patients with oxygen blood saturation of less than 94% at room air.
Contacts and Locations| Israel | |
| Intensive Cardiac Care Unit, assaf harofhe medical center | Recruiting |
| Zerifin, Israel | |
| Contact: Sahar Minha, Dr minha.saar@gmail.com | |
| Contact: Keren Doenyas, Dr 972-544-215487 kerendoenyas@gmail.com | |
| Principal Investigator: Alex Blat, Dr | |
More Information
No publications provided
| Responsible Party: | Fany Tusia, medical center, Assaf-Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT01448889 History of Changes |
| Other Study ID Numbers: | cino2 |
| Study First Received: | April 6, 2011 |
| Last Updated: | October 6, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Assaf-Harofeh Medical Center:
|
contrast induced nephropathy oxigen coronary angiography |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013