CompletedPhase 3

Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure

France150 participantsStarted 2017-02-10

Plain-language summary

IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: * ICU stay \> 7 days * Having presented during the stay renal failure stage 2 or 3 Kidney Disease Improving Global Outcomes (KDIGO) * Steady improvement of renal function before the ICU discharge : * Creatinine before ICU discharge \<110 µmol / L for women, \<130 µmol / L for men * No recourse to extra renal purification * Change in creatinine levels (ΔCréatinine) less than 20% over two measures spaced 24 hours within 48 hours preceding the discharge * Expected discharge ICU within 48 hours : * Glasgow score \> 13 * Lack of mechanical ventilation except home Noninvasive Mechanical Ventilation (NiMV) * Lack of use of catecholamine * No contra-indication for discharge according to physician in charge of the patient * Informed consent signed by the patient, where not possible by the person of trust or the family if present. Written consent by the patient will be obtained as soon as deemed possible. Exclusion Criteria: * Iohexol administration within 48 hours preceding the potential inclusion (imaging examination with X-ray contrast medium injection) * Iohexol administration planned within 24 hours after potential inclusion in the study * Known medical history of immediate allergic or delayed skin allergic reaction to injection of iodinated contrast material or any serious doubt on this medical history * Patient receiving from extra renal purification during ICU discharge * Chronic renal disease known (creatinine\> 110 µmol / L for women,\> …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.

Timeframe: 24 hours

Trial details

NCT IDNCT02961478

SponsorUniversity Hospital, Angers

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-11-11

View on ClinicalTrials.gov More Acute Renal Failure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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