Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fany Tusia, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01448889
First received: April 6, 2011
Last updated: October 6, 2011
Last verified: October 2011
  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.

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • contrast induced nephropathy [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
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: NCT01448889

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         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  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 October 23, 2014