NACAM: NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Sponsor
Kaiser Permanente (Other)
Overall Status
Recruiting
CT.gov ID
NCT04750616
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Beth Israel Deaconess Medical Center (Other), Cedars-Sinai Medical Center (Other)
304
1
2
45.5
6.7

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Sep 13, 2021
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Troponin T AUC [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 [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 [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 [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. [From baseline through day 90]

    • Mean length of index hospital stay (days)

  3. Length of intensive care unit stay. [From baseline through day 90]

    • Mean length of intensive care unit stay (days)

  4. Perioperative inotropic-score and vasoactive-inotropic score. [At 6, 12, 24, and 48 hours post operatively]

    • Mean inotropic-score and vasoactive-inotropic score

  5. Perioperative fluid volume administration. [From baseline through day 2]

    • Mean daily perioperative fluid volume administration

  6. Perioperative brain-natriuretic peptide AUC [From baseline to three days after surgery]

    BNP AUC, composed of single daily serum measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 Kaiser Permanente San Francisco Medical Center San Francisco California United States 94115

Sponsors and Collaborators

  • Kaiser Permanente
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Beth Israel Deaconess Medical Center
  • Cedars-Sinai Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT04750616
Other Study ID Numbers:
  • 1620125
First Posted:
Feb 11, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Jun 30, 2022