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

NCT07203131 | Recruiting

• 1 other identifier: 2023-A01709-36
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Renal Insufficiency; NAD

Outcome Measures

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

  2 days

Secondary Outcomes (4)

• ARI Features : severity of ARI

  12 hours

• Duration or ARI

  between 1 day and 28 days

• Cardiovascular complications

  between day 1 and day 7

• Patient follow-up

  28 days

Study Arms (1)

Patient admitted to intensive care for a high-risk reason of ARI

EXPERIMENTAL

Patient admitted to intensive care for a high-risk reason of ARI : Shock, Sepsis, Cardiovascular arrest, Post-operative unscheduled surgery, Post-operative cardiac surgery

Diagnostic Test: Urine sample; Other: Phone call at day 28

Interventions

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

Patient admitted to intensive care for a high-risk reason of ARI

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.

Patient admitted to intensive care for a high-risk reason of ARI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
• Pregnant, breastfeeding or parturient woman.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital Privé de l'Ouest Parisien

Trappes, 78190, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Matthieu JAMME, Dr

CONTACT

00336 87 64 61 12; mat.jamme@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: October 2, 2025
• Study Start: March 17, 2025
• Primary Completion: November 5, 2025
• Study Completion: December 5, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)