NL-OMON34419RecruitingPhase 2
Efficacy and safety of forced diuresis and guided fluid replacement therapy on contrast media induced nephropathy; a feasibility study - Forced diuresis and guided fluid replacement in CIN Prevention
niversitair Medisch Centrum Sint Radboud0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 <20(excluded);* NYHA III/IV or history of pulmonary edema
- •** systolic blood pressure <80mmHg for 1 hour requiring inotropic support or IABP
- •within 24 h periprocedurally
- •*** baseline Ht<39% for men, <36% for women
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 <90% on room air assessed on day of procedure.
- •3.Hypotension systolic blood pressure <110mmHg.
- •4.Significant arrhythmias which compromise subject*s hemodynamic state.
- •5.Intra-aortic balloon pump use.
- •6.eGFR (MDRD) <20 ml/min 1.73 m2
- •7.Active urinary tract infection/or recurrent urinary tract infection.
- •8.Abnormal bladder function.
- •9.Known inability to place a Foley catheter.
- •10.Change in GFR >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 <3,0 mmol/L..
- •16.Subject has known hypersensitivity of furosemide.
- •17.Participation in another study in the past 30 days
- •18.If female subject is pregnant or breastfeeding.
- •19.Subject is unable to provide written informed consent.
Investigators
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