Efficacy and safety of forced diuresis and guided fluid replacement therapy on contrast media induced nephropathy; a feasibility study

Phase 2

Recruiting

• Conditions: kidney damage because of contrast agents; 10011082; 10029149

• Registration Number: NL-OMON34419
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoints<br /><br>1. The development of contrast induced nephropathy defined as a rise in serum<br /><br>creatinine of > 25% 48 to 72 hours after administration.<br /><br>2. Development of overhydration/pulmonary edema or other adverse events;<br /><br>hypotension or clinically significant changes in electrolytes</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints (if applicable)<br /><br>Ability to match in and output, time to desired diuresis >200ml/hour<br /><br>Incidence of hypokaliemia<br /><br>Logistics of protocol</p><br>