Study Summary
This trial was designed to study the effectiveness of a drug called Nam for preventing acute kidney injury in patients undergoing heart surgery.
Eligible Conditions
- Myocardial Injury
- Acute Kidney Injury
- Ischemia Reperfusion Injury
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: At 6, 12, 24, and 48 hours post operatively
Hour 48
Perioperative inotropic-score and vasoactive-inotropic score.
Day 2
Perioperative fluid volume administration.
Day 5
Mean difference in eGFR
Day 90
Length of index hospital stay.
Length of intensive care unit stay.
Number of Participants with the following Adverse Events and Serious Adverse Events
From baseline to three days after surgery
Mean difference in uQuin/Tryp ratio AUC
Perioperative brain-natriuretic peptide AUC
Troponin T AUC
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Vorinostat (SAHA) and Niacinamide: Level 2
100%Nausea
67%Diarrhea
67%Fatigue
67%Fever
67%Neutropenia
67%Thrombocytopenia
67%Anorexia
67%Vomitiing
67%Constipation
33%Right Eye Redness
33%Difficulty initiating urinary stream
33%Left Eye Redness
33%Left lower quadrant abdominal pain
33%Suprapubic pain
33%Trace Edema
33%Headache
33%Ache
33%ALT
33%Dizziness
33%Cough
33%Decrease in taste
33%Dehydration
33%Dysuria
33%Slight cough
33%Slight dry cough
33%Hyperglycemia
33%Hypoalbuminemia
33%Hypotension
33%Incontinence
33%Leakage from rectum
33%Left Breast Itchy Rash
33%Right Side Mouth Sore
33%Runny Nose
33%Ulcerations in mouth
33%UTI
33%Anxiety
33%AST
33%Occational lightheadedness
33%Abdominal pain
33%Anemia
33%Burning with Urination
33%Chest tightness
33%Clots in Urine
33%Creatinine
33%Hematuria
33%Joint Aches
33%Redness & slight bump on right of nose
33%Rigors
33%Short-term memory loss
33%Slight hoarseness
33%Urgency with urination
33%Sinus Tachycardia
33%Vomiting
33%Weight loss
33%Yeast Infections and infestations
Trial Design
2 Treatment Groups
Oral niacinamide
1 of 2
Matched placebo
1 of 2
Experimental Treatment
Non-Treatment Group
304 Total Participants · 2 Treatment Groups
Primary Treatment: Niacinamide · Has Placebo Group · Phase 2
Oral niacinamide
Drug
Experimental Group · 1 Intervention: Niacinamide · Intervention Types: DrugMatched placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 6, 12, 24, and 48 hours post operatively
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,591 Previous Clinical Trials
46,945,643 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
777 Previous Clinical Trials
845,732 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
508 Previous Clinical Trials
22,255,044 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
456 Previous Clinical Trials
153,931 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes.
You have aortic, mitral, tricuspid, or pulmonic valve replacement or repair.
The eGFR is less than 45 ml/min/1.73m2.
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Conditions
Cancer Related
Treatments