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Recruiting NCT04750616

NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Phase II Interventional Ischemia Reperfusion Injury Myocardial Injury Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Niacinamide, Placebo.
Who it may be relevant to
Registry conditions: Ischemia Reperfusion Injury, Myocardial Injury, Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial

Overview

A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery

Detailed description

This trial is a single-center, randomized, double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery. After screening and enrollment, patients will be stratified according to CKD status (eGFR\<45 ml/min/m2) and surgical site and randomized in a 1:1 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two.

The overall trial duration is planned for 42 months, consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled.

Interventions

  • Drug Niacinamide
    Niacinamide 3 grams on the day of surgery and post-surgical days one and two
  • Drug Placebo
    Matched placebo on the day of surgery and post-surgical days one and two

Primary outcome measures

  • Troponin T AUC [Time frame: From baseline to three days after surgery]
Secondary outcome measures (2)
  • Mean difference in uQuin/Tryp ratio AUC [Time frame: From baseline to three days after surgery]
  • Mean difference in eGFR [Time frame: From baseline through day 5.]

Eligibility criteria

Inclusion criteria

  • Informed consent before any study-related activities.
  • Men or women >18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes.

Procedures include:

  • CABG
  • Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
  • CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement

Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following:

  • Valve surgery
  • eGFR < 45 ml/min/1.73m2
  • Documented LVEF ≤ 35% within six months before surgery
  • Documented history of heart failure
  • Insulin-requiring diabetes
  • Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio)
  • Preoperative anemia (hemoglobin <11g/dl for men and women)
  • History of prior CABG
  • Age ≥65

Exclusion criteria

  • Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
  • Kidney transplant status
  • Off-pump cardiac surgery
  • ESRD
  • Emergent cardiac surgery
  • Pregnancy
  • Patient enrolled in competing research studies that may affect outcomes
  • Patients held in an institution by legal or official order

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Kaiser Permanente San Francisco Medical Center — San Francisco

Publications

  • Scurt FG, Bose K, Mertens PR, Chatzikyrkou C, Herzog C. Cardiac Surgery-Associated Acute Kidney Injury. Kidney360. 2024 Jun 1;5(6):909-926. doi: 10.34067/KID.0000000000000466. Epub 2024 May 1. PMID 38689404

Identifiers

NCT: NCT04750616 · 1620125

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗