Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy

NCT01448889 | Unknown

• 1 other identifier: cino2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephropathy

Keywords

contrast induced nephropathy; oxigen; coronary angiography

Outcome Measures

Primary Outcomes (1)

• contrast induced nephropathy

  48 hours

Secondary Outcomes (4)

• Nitric Oxide in urine sample

  day -1, and 6,24,48 hours after exposure

• urinary isoprostanes

  day -1, and 6,24,48 hours after exposure

• blood urea and creatinin

  day -1, and 6,24,48 hours after exposure

• cystatin-C

  day -1, and 6,24,48 hours after exposure

Study Arms (2)

100% oxigen

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

100% oxigen DRUG

patients will recive 100% oxigen in a mask with reservoir from the begginind of the procedure to 4 hours after its termination

100% oxigen

placebo DRUG

patients will recive 21% oxigen (room air) in a mask with reservoir from the begginind of the procedure to 4 hours after its termination

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective coronary angiography
• estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2
• inform consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Intensive Cardiac Care Unit, assaf harofhe medical center

Ẕerifin, Israel

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical center

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: October 7, 2011
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 7, 2011

Record last verified: 2011-10

Locations

IL (1)