Impact of Nicotinamide Riboside (NR) on Kidney Function in Patients Undergoing Cardiac Surgery

NCT06521307 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-25

No results posted yet for this study

Summary

Acute kidney injury (AKI) associated with cardiac surgery is the most important complication in adult patients undergoing open heart surgery and is associated with increased mortality and morbidity. In patients in intensive care units, it is the second most common type of AKI after AKI secondary to sepsis. There is currently no specific treatment for AKI. Supportive measures include renal support therapy for patients with severe AKI, and mortality in this subgroup of patients exceeds 50%. Increasing NAD+ with niacinamide has been shown to prevent various etiologies of experimental AKI in mice, and an early pilot study has shown both increased NAD levels following administration of nicotinamide riboside with pterostilbene NPRT and the safety of niacinamide in patients undergoing cardiac surgery.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nicotinamide riboside

We will recruit the participant 24 hrs prior intervention, once the participant decides to enroll, we will administer by oral intake the supplement or placebo due to the result at randomizer.org. The first NAD Riboside arm will be administered by oral intake with 2000 mg at enrollment, then we will administer 3000mg prior undergoing surgery with NG tube, 3000mg 12 hrs post-surgery with NG tube and 2000mg by oral intake 24 hrs after intervention. All the administrations with NG tube will be flushed with 0.9% saline solution.

OTHER

Placebo

We will recruit the participant 24 hrs prior intervention, once the participant decides to enroll, we will administer by oral intake the supplement or placebo due to the result at randomizer.org. The first dose of placebo arm will be administered by oral intake with 2000 mg at enrollment, then we will administer 3000mg prior undergoing surgery with NG tube, 3000mg 12 hrs post-surgery with NG tube and 2000mg by oral intake 24 hrs after intervention. All the administrations with NG tube will be flushed with 0.9% saline solution.

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

    lead OTHER

Principal Investigators

  • Magdalena Madero · Instituto Nacional de Cardiología. Ignacio Chávez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2025-07-31
Completion
2026-07-24

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521307 on ClinicalTrials.gov