Altering NAD+ metabolism to improve kidney outcomes after ICU admission
Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care
NA · Ramsay Générale de Santé · NCT07203131
This study will see if changes in NAD+ metabolism are linked to acute kidney injury in adults admitted to intensive care who have normal kidney function on arrival.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ramsay Générale de Santé (other) |
| Locations | 1 site (Trappes) |
| Trial ID | NCT07203131 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adults admitted to an ICU for conditions with a high risk of acute renal injury and with normal renal function at admission. Investigators collect urine samples to measure NAD+–related metabolites and follow patients' renal course during their stay with a phone follow-up at day 28. The protocol excludes people with prior chronic kidney disease, kidney transplant recipients, minors, patients admitted for low-AKI-risk reasons, and those unable to consent. Results will correlate NAD+ pathway alterations with incidence, severity, and duration of acute kidney injury.
Who should consider this trial
Good fit: Adults over 18 admitted to intensive care for high-risk reasons (shock, sepsis, cardiac arrest, unscheduled surgery, or cardiac surgery) who have normal kidney function on admission and can give informed consent are ideal candidates.
Not a fit: Patients with pre-existing chronic kidney disease or a kidney transplant, minors, those admitted for low-AKI-risk reasons, or patients unable to provide consent are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, identifying NAD+ metabolism changes could allow earlier detection of patients at high risk of AKI and point to treatments, such as vitamin B3, to prevent or reduce kidney injury.
How similar studies have performed: Prior animal and human work and a phase 2 trial in cardiac surgery patients have suggested that boosting NAD+ (for example with vitamin B3) can reduce AKI, so there is encouraging preliminary evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Trappes
- Hôpital Privé de l'Ouest Parisien — Trappes, France (RECRUITING)
Study contacts
- Study coordinator: Matthieu JAMME, Dr
- Email: mat.jamme@gmail.com
- Phone: 00336 87 64 61 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Renal Insufficiency, NAD