kidney damage because of contrast agents
Conditions
Interventions
The treatment consists of induced diuresis with matched hydration therapy,
using the RenalGuard System. The purpose of matched fluid replacement is to
provide sterile replacement solution to a patie
pink) will be inserted for
hydration. The system requires the use of a standard Foley catheter, which will
be inserted to allow the measurement of urine produced by the patient.
As the system requir
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (see table 1) 1.Male or female>18 years 2.Scheduled to undergo a non-emergent catheterization procedure, with or without additional other procedures (e.g. left ventriculography, imaging of grafts, stenting etc.) 3.A Mehran risk score > 6 (score 6-10 CIN risk: 14%) Mehran Risk score: Congestive heart failure* 5 (excluded) Hypotension** 5 (excluded) Intra-aortic balloon pump use 5 (excluded) Age >75 yrs 4 Anemia*** 3 Diabetes mellitus 3 Contrast volume 1 for each 100 ml Estimated glomerular filtration rate (ml/min 1.73 m2) MDRD 2 for 40 to 60, 4 for 20 to 40, 6 for
Exclusion criteria
Exclusion criteria: (see table1) 1.Severe heart failure :NYHA III/IV or history of pulmonary edema. 2. Has documented respiratory insufficiency, dyspnoea at rest, oxygen saturation 25% in the last month 11.M Kahler/ M Waldenström. 12.Use of NSAID's, other nefrotoxic drugs, or drugs that interfere with creatinine handling (e.g. aminoglycosiden, cisplatinum, mannitol, lithium, trimethoprim). 13.Catheterization procedure requiring a direct renal injection of contrast or an injection into the descending aorta proximal to the renal arteries. 14.Requiring emergent catheterization. 15.Serum potassium concentration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoints 1. The development of contrast induced nephropathy defined as a rise in serum creatinine of > 25% 48 to 72 hours after administration. 2. Development of overhydration/pulmonary edema or other adverse events; hypotension or clinically significant changes in electrolytes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints (if applicable) Ability to match in and output, time to desired diuresis >200ml/hour Incidence of hypokaliemia Logistics of protocol | — |
Countries
Netherlands
Outcome results
None listed