Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury

NCT ID: NCT02701127

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-31

Brief Summary

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This is a single center, randomized, single-blind, placebo-controlled study to evaluate the safety and biochemical effects of niacinamide on metabolic parameters of the kidney in patients undergoing cardiac surgery.

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Niacinamide 1 gram

Oral niacinamide, 1 gram daily

Group Type ACTIVE_COMPARATOR

Oral niacinamide, 1 gram daily

Intervention Type DRUG

Niacinamide 3 grams

Oral niacinamide, 3 grams daily

Group Type ACTIVE_COMPARATOR

Oral niacinamide, 3 gram daily

Intervention Type DRUG

Placebo

Oral placebo pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Oral niacinamide, 1 gram daily

Intervention Type DRUG

Oral niacinamide, 3 gram daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass at high risk for acute kidney injury. A Cleveland score of 6 or more is used to define patients at high risk for acute kidney injury
2. Age ≥ 18
3. Signed informed consent

Exclusion Criteria

1. Pre-existing acute kidney injury
2. Kidney transplantation
3. Off-pump heart surgery
4. Pregnancy
5. End stage renal disease
6. Pregnancy (female subjects of childbearing potential must have a negative serum pregnancy test)
7. Subjects with any kind of dependency on the investigator (e.g. any subject who is under direct supervision of the investigator/co-investigators or employed by the investigator/co-investigators) 8 Subjects held in an institution by legal or official order (e.g. subjects in jail, prison, juvenile offender facility, or treatment facility including those who are in hospitals, alcohol, and drug treatment facilities under court order, and individuals with psychiatric illnesses who have been committed involuntarily to an institution)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ali Poyan Mehr

Instructor in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2016P000028

Identifier Type: -

Identifier Source: org_study_id

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