Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care (NI-AKI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urine sample, Phone call at day 28.
- Who it may be relevant to
- Registry conditions: Acute Renal Insufficiency, NAD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care
Overview
Among all patients admitted to intensive care, it is estimated that more than half of them are exposed during their stay to acute renal failure (ARF). Impacting the vital prognosis to short term, the occurrence of renal failure is not without consequences in intensive care survivors, presenting an increased risk of death mainly mediated by an excess risk with regard to chronic kidney disease and/or certain cardiovascular pathologies. Malnutrition, particularly vitamin deficiency, has already been reported as a risk factor for AKI. Studies on two models (animal and human) have recently highlighted the importance of NAD+ production failure in the onset of renal failure. NAD+ synthesis can be done from tryptophan or via a salvage pathway from vitamin PP. In a phase 2 study in patients undergoing cardiac surgery, vitamin B3 supplementation was accompanied by a reduction in the occurrence of AKI and a limitation of the duration / intensity of renal dysfunction. This innovative research aims to identify an alteration in the metabolic pathway of NAD+ production as a risk factor for AKI in intensive care patients. This would be the first study to address this issue in this specific population. The main objective of this research is to describe the association between the urinary Quinolinate/Tryptophan ratio on admission and the occurrence of acute renal failure in patients admitted to intensive care unit.
Interventions
- Diagnostic test Urine sample
5 mL of urine when the patient is admitted in intensive care To look for possible acute renal failure in the patient - Other Phone call at day 28
It will allow the following information to be collected: * Post-resuscitation monitoring and length of hospitalization, * Vital status, * Collection of adverse events, * Concomitant treatments.
Primary outcome measures
- Acute renal insufficiency [Time frame: 2 days]
Secondary outcome measures (4)
- ARI Features : severity of ARI [Time frame: 12 hours]
- Duration or ARI [Time frame: between 1 day and 28 days]
- Cardiovascular complications [Time frame: between day 1 and day 7]
- Patient follow-up [Time frame: 28 days]
Eligibility criteria
Inclusion criteria
- Patient, male or female aged over 18,
- Patient admitted to intensive care for a reason with a high risk of ARI: shock, sepsis, cardio-circulatory arrest, post-operative unscheduled surgery, post-operative cardiac surgery,
- Patient with normal renal function on admission,
- Patient affiliated to or beneficiary of a social security scheme,
- Patient having been informed and having given his/her free, informed and written consent
Exclusion criteria
- Minor patient,
- History of chronic kidney disease,
- History of kidney transplant,
- Admission for a reason with a low risk of ARI (neuroresuscitation, voluntary drug intoxication with anxiolytics - antidepressants - psychotropic drugs),
- Acute non-infectious respiratory failure, (scheduled surgery other than cardiac surgery)
- Patient hospitalized without consent,
- Patient in a period of exclusion due to another research still in progress at the time of inclusion,
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
- Pregnant, breastfeeding or parturient woman.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 1 center
- Hôpital Privé de l'Ouest Parisien — Trappes
Identifiers
NCT: NCT07203131 · 2023-A01709-36