NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Acute Kidney Injury Clinical Trial

— NACAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750616
• Other study ID #: 1620125
• Status: Recruiting
• Phase: Phase 2
• Start date: September 13, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Kaiser Permanente
• Contact: Ali Poyan Mehr, MD
• Phone: 4152644750
• Email: ali.x.poyanmehr[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Ischemia
• Ischemia Reperfusion Injury
• Myocardial Injury
• Reperfusion Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente San Francisco Medical Center	San Francisco	California

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with the following Adverse Events and Serious Adverse Events	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)	From baseline through day 90
Other	Length of index hospital stay.	• Mean length of index hospital stay (days)	From baseline through day 90
Other	Length of intensive care unit stay.	• Mean length of intensive care unit stay (days)	From baseline through day 90
Other	Perioperative inotropic-score and vasoactive-inotropic score.	• Mean inotropic-score and vasoactive-inotropic score	At 6, 12, 24, and 48 hours post operatively
Other	Perioperative fluid volume administration.	• Mean daily perioperative fluid volume administration	From baseline through day 2
Other	Perioperative brain-natriuretic peptide AUC	BNP AUC, composed of single daily serum measurements	From baseline to three days after surgery
Primary	Troponin T AUC	Troponin T AUC, composed of single daily serum measurements	From baseline to three days after surgery
Secondary	Mean difference in uQuin/Tryp ratio AUC	Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements	From baseline to three days after surgery
Secondary	Mean difference in eGFR	Mean difference in eGFR (CKD-EPI formula)	From baseline through day 5.