TerminatedPhase 4

Double-Blind Placebo-Controlled CIN Trial

Stopped: Insufficient number of subjects could be enrolled.

United States1 participantsStarted 2015-07

Plain-language summary

This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease. Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inpatients scheduled for CT scan of abdomen and/or pelvis * Had surgery in the last 4 weeks * Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of CT) * Suspected infection or fluid collection in abdomen and/or pelvis Exclusion Criteria: * Pregnant * Severe Allergy (anaphylaxis) to contrast * Dialysis in last 7 days * Received intravascular iodinated contrast in last 48 hours * CT of abdomen and pelvis in last 7 days shows no fluid collection * Prisoners * CT ordered for an indication that requires (eg, CT angiogram) or contraindicates (eg, renal stone CT) the administration of intravascular contrast

What they're measuring

Participants With Stage II AKI (Acute Kidney Injury)

Timeframe: 48 hours

Trial details

NCT IDNCT02467075

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

Results submitted2017-04-03

View on ClinicalTrials.gov More Acute Kidney Injury trials