Contrast-Induced Nephropathy
Conditions
Interventions
Oxygen preconditioning group: Single-blinded trans nasal oxygen administration (2L/min) via high-pressure oxygen cylinder 10 to 15 minutes prior to the contrast enhanced computed tomography
Norma
Sponsors
National Hospital Organization Yokohama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients for whom the contrast enhanced computed tomography were scheduled at hospitals belonging to National Hospital Organization
Exclusion criteria
Exclusion criteria: 1)Patients within 2 weeks after the acute coronary syndromes (acute myocardial infarction, unstable angina) 2)Patients presenting shock (systolic blood pressure <90 mmHg) 3)Patients with a history of a severe contrast medium allergy 4)Patients with chronic kidney disease which eGFR less than 30 mL/min/1.73m2 5)Patients were administrated the contrast medium within 10 days 6) Patients with oxygen saturation of peripheral artery:SpO2 less than 90% recorded 7)Patients with chronic obstructive pulmonary disease or patients with risks for CO2 narcosis (including history of CO2 narcosis) 8)Patients receiving home oxygen therapy 9)Patients undergoing hemodialysis or peritoneal dialysis 10)Patients who have taken biguanides within 48 hours 11) Patients with severe infections, patients in the perioperative period, or those with serious injury, poor nutritional status, in a starvation state, or state of debility 12)Patients that are scheduled operation within two weeks 13) Patients with confirmed or suspected rhabdomyolysis 14) Patients with confirmed or suspected pituitary or adrenal insufficiency 15) Patients with paraquat poisoning 16)Patients who are pregnant or may be pregnant 17)Patients with piece renal,renal hypoplasia,or nephrectomy (including partial nephrectomy) 18)Patients administrated oxygen 24 hours before the contrast enhanced computed tomography 19)Patients for whom planing the treatment by intravenous drip infusion or oral rehydration therapy 20)Patients will be undergoing emergency computed tomography 21)Patients can not have a oral rehydration therapy 22)Patients whose doctors judged them as unsuited to participate in this clinical study 23)Patients during the follow-up period of this clinical study or with the history of participation to this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CIN within 72 hours after the contrast enhanced computed tomography | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The incidence rate of CIN in control group 2) Exploratory data analysis regarding risk factors of CIN 3) Short- and medium- term prognosis (chronic kidney diseases as the estimated glomerular filtration rate: eGFR less than 60ml/min/1.73m2, hemodialysis, and total death) within 72 hours and 28 days after the contrast enhanced computed tomography 4, 5) Kidney markers at 48 hours and 28 days after the contrast enhanced computed tomography (creatinine, cystatin C, urinary NAG, urinary protein, urinary L-FABP, Nox) 6) Sub-analysis: Sub-analysis conducted with renal dysfunction patients (with eGFR less than 45ml/min/1.73m2) 7) Sub-analysis: Sub-analysis considering of the volume of oral rehydration solution named OS-1) 8) Sub-analysis: Sub-analysis conducted in the level of diabetes mellitus (HbA1c more than or equal 7.0 % or less than 7.0 %) 9) Sub-analysis: Sub-analysis for acute kidney injury (AKI) by categorization of AKIN: Acute Kidney Injury Network 10) Sub-analysis: Sub-analysis for CIN and AKI by eGFR, CLCr: eGFR using Cockcroft-Gault, and eGFR calculated by cystatin C 11) Sub-analysis: Sub-analysis for incidence rate of CIN regarding the type of contrast medium, and the volume of contrast medium | — |
Countries
Japan
Contacts
Public ContactYoshimi Seki
National Hospital Organization Yokohama Medical Center Clinical Research Department
Outcome results
None listed