Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care (NI-AKI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRamsay Générale de Santé

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial design

Design model

Single group

Treatments tested in this trial

  • Urine sample

    Diagnostic test

    5 mL of urine when the patient is admitted in intensive care To look for possible acute renal failure in the patient

  • Phone call at day 28

    Other intervention

    It will allow the following information to be collected: * Post-resuscitation monitoring and length of hospitalization, * Vital status, * Collection of adverse events, * Concomitant treatments.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patient admitted to intensive care for a high-risk reason of ARIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Acute renal insufficiency

* An increase in creatinine ≥ 0.3 mg/dL (26.5 μmol/L) within 48 hours * Or an increase in creatinine ≥ 1.5 times the baseline value * Or a urine volume \< 0.5 mL/kg/h over a 6-hour period * Urinary Quinolinate/Tryptophan (Q/T) ratio on admission

Time frame
2 days

Secondary outcomes

1

ARI Features : severity of ARI

* grad 1 : creatinine between 1.5 and 1.9 times the baseline value OR increase ≥ 0.3 mg/dL (26.5 μmol/l) and urine \< 0.5 mL/kg/h over a period of 6h to 12h * grad 2 : creatinine between 2.0 and 2.9 times the base value and urine \< 0.5 mL/kg/h over a duration ≥12 * grad 3 : creatinine greater than or equal to 3.0 times the baseline value OR increase ≥ 4.0 mg/dL (353.6 μmol/L) OR use of extra-renal purification OR patients under 18 years of age with decrease in creatinine clearance \< 35 mL/min per 1.73 m² and urine \< 0.3 mL/kg/h over a duration of ≥24h OR anuria over a duration of ≥12h

Time frame
12 hours
2

Duration or ARI

Duration in days of ARI

Time frame
between 1 day and 28 days
3

Cardiovascular complications

* evolution of the troponin level between D1 and D7, * Use of mechanical ventilation and duration, * Evolution of the SOFA score between D1 and D7

Time frame
between day 1 and day 7
4

Patient follow-up

Mortality within 28 days of admission to intensive care, NI-AKI * Number of days alive outside intensive care within 28 days of admission to intensive care, * Number of days alive not hospitalized within 28 days of admission to intensive care.

Time frame
28 days

Other outcomes

Sponsors and contacts

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