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NCT Number: NCT07203131

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé de l'Ouest Parisien

Trappes, 78190, France

Location status: Recruiting

Location contact

Matthieu JAMME, Dr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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 outcomes

  1. Acute renal insufficiency

    Time frame: 2 days

    • 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

Secondary outcomes

  1. ARI Features : severity of ARI

    Time frame: 12 hours

    • 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
  2. Duration or ARI

    Time frame: between 1 day and 28 days

    Duration in days of ARI

  3. Cardiovascular complications

    Time frame: between day 1 and day 7

    • evolution of the troponin level between D1 and D7,
    • Use of mechanical ventilation and duration,
    • Evolution of the SOFA score between D1 and D7
  4. Patient follow-up

    Time frame: 28 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthieu JAMME, Dr

CONTACT

[email protected]

00336 87 64 61 12

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care

Acronym: NI-AKI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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