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

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ClinicalTrials.gov Identifier: NCT04750616
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : September 27, 2021
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Beth Israel Deaconess Medical Center
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Ischemia Reperfusion Injury Myocardial Injury Acute Kidney Injury Drug: Niacinamide Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
Actual Study Start Date : September 13, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral niacinamide Drug: Niacinamide
Niacinamide 3 grams on the day of surgery and post-surgical days one and two
Placebo Comparator: Matched placebo Drug: Placebo
Matched placebo on the day of surgery and post-surgical days one and two


Outcome Measures
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Primary Outcome Measures :
  1. Troponin T AUC [ Time Frame: From baseline to three days after surgery ]
    Troponin T AUC, composed of single daily serum measurements


Secondary Outcome Measures :
  1. Mean difference in uQuin/Tryp ratio AUC [ Time Frame: From baseline to three days after surgery ]
    Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements

  2. Mean difference in eGFR [ Time Frame: From baseline through day 5. ]
    Mean difference in eGFR (CKD-EPI formula)


Other Outcome Measures:
  1. Number of Participants with the following Adverse Events and Serious Adverse Events [ Time Frame: From baseline through day 90 ]
    • Postoperative dysrhythmias
    • Postoperative re-hospitalization.
    • Heart failure
    • Surgical wound infection
    • Transfusion requiring perioperative bleed
    • Post-surgical deep vein thrombosis and pulmonary emboli
    • Nosocomial infection
    • Nausea and vomiting
    • Adverse events leading to treatment discontinuation
    • Perioperative liver injury (x2 upper normal-limit)
    • Post-operative thrombosis and pulmonary emboli
    • Impairment of renal function (KDIGO AKI)

  2. Length of index hospital stay. [ Time Frame: From baseline through day 90 ]
    • Mean length of index hospital stay (days)

  3. Length of intensive care unit stay. [ Time Frame: From baseline through day 90 ]
    • Mean length of intensive care unit stay (days)

  4. Perioperative inotropic-score and vasoactive-inotropic score. [ Time Frame: At 6, 12, 24, and 48 hours post operatively ]
    • Mean inotropic-score and vasoactive-inotropic score

  5. Perioperative fluid volume administration. [ Time Frame: From baseline through day 2 ]
    • Mean daily perioperative fluid volume administration

  6. Perioperative brain-natriuretic peptide AUC [ Time Frame: From baseline to three days after surgery ]
    BNP AUC, composed of single daily serum measurements


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750616


Contacts
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Contact: Ali Poyan Mehr, MD 4152644750 ali.x.poyanmehr@kp.org

Locations
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United States, California
Kaiser Permanente San Francisco Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Ali Poyan Mehr, MD         
Sub-Investigator: Ahmad Sheikh, MD         
Sub-Investigator: Andrew Avins, MD         
Sub-Investigator: Lance Rtherford, MD         
Sub-Investigator: Paul LaPunzina, MD         
Sponsors and Collaborators
Kaiser Permanente
National Heart, Lung, and Blood Institute (NHLBI)
Beth Israel Deaconess Medical Center
Cedars-Sinai Medical Center
More Information
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT04750616    
Other Study ID Numbers: 1620125
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Reperfusion Injury
Ischemia
Wounds and Injuries
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Niacinamide
 Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents