NCT02761577

Brief Summary

The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function. Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion. Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 48-72 hours after the procedure

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

April 29, 2016

Last Update Submit

May 2, 2016

Conditions

Kidney DiseasesContrast Media Reaction

Keywords

AcetylcysteineSodium BicarbonateLipocalinsCreatinineBlood Urea Nitrogen

Outcome Measures

Primary Outcomes (1)

  • renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL

    measure of serum creatinine before and after diagnostic procedure

    48 hours

Secondary Outcomes (2)

  • blood urea nitrogen in mmol/L

    48 hours

  • neutrophil gelatinase-associated lipocalin in ng/mL

    48 hours

Study Arms (3)

control

NO INTERVENTION

perorally 1500 ml water on the day of the procedure

Sodium bicarbonate

EXPERIMENTAL

3 mL/kg/hour IV (in vein) of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography

Drug: Sodium bicarbonate

N-acetylcysteine plus Sodium bicarbonate

EXPERIMENTAL

N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Sodium bicarbonate solution on the day of the angiography.

Drug: Sodium bicarbonateDrug: N-acetylcysteine

Interventions

Sodium bicarbonateDRUG

3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography

Also known as: NaHCO3
N-acetylcysteine plus Sodium bicarbonateSodium bicarbonate
N-acetylcysteineDRUG

N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure

Also known as: fluimukan
N-acetylcysteine plus Sodium bicarbonate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • angina (stable, unstable)
  • coronary artery disease
  • cardiomyopathy
  • valvular disease
  • vasculitis
  • peripheral arterial disease

You may not qualify if:

  • kidney dysfunction
  • uncontrolled hypertension (systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg)
  • pregnancy
  • lactation
  • history of allergic reaction to contrast agents
  • cardiogenic shock
  • pulmonary edema
  • multiple myeloma
  • urgent coronary angiography
  • receiving contrast agents two days prior to the study and 48 hours within the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Diseases

Interventions

Sodium BicarbonateAcetylcysteine

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsCysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PhD

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 4, 2016

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

April 1, 2016

Last Updated

May 4, 2016

Record last verified: 2016-05