Clinical trial NCT04750616: NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Official title: NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ischemia Reperfusion Injury
Myocardial Injury
Acute Kidney Injury
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Beth Israel Deaconess Medical Center
name: Cedars-Sinai Medical Center
First posted: 2021-02-11
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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

Primary outcomes:
measure: Troponin T AUC
timeFrame: From baseline to three days after surgery
Secondary outcomes:
measure: Mean difference in uQuin/Tryp ratio AUC
timeFrame: From baseline to three days after surgery
measure: Mean difference in eGFR
timeFrame: From baseline through day 5.
Other outcomes:
measure: Number of Participants with the following Adverse Events and Serious Adverse Events
timeFrame: From baseline through day 90
measure: Length of index hospital stay.
timeFrame: From baseline through day 90
measure: Length of intensive care unit stay.
timeFrame: From baseline through day 90
measure: Perioperative inotropic-score and vasoactive-inotropic score.
timeFrame: At 6, 12, 24, and 48 hours post operatively
measure: Perioperative fluid volume administration.
timeFrame: From baseline through day 2
measure: Perioperative brain-natriuretic peptide AUC
timeFrame: From baseline to three days after surgery
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
Study officials:
References: