NCT00950079

Brief Summary

The aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
368

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

9 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2009

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 31, 2009

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

July 6, 2009

Last Update Submit

July 30, 2009

Conditions

Contrast Induced Nephropathy

Keywords

sodium bicarbonatediabetes mellituscoronary angiography or intervention

Outcome Measures

Primary Outcomes (1)

  • Incidence of contrast-induced nephropathy

    24 and 48 hours after angiography or intervention

Secondary Outcomes (8)

  • all-cause mortality

    30 days after index angiography

  • stroke

    30 days after index angiography

  • Dialysis

    30 days after index angiography

  • Myocardial infarction

    30 days after index angiography

  • all-cause mortality

    30 days to 6 months after index angiography

  • +3 more secondary outcomes

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

sodium bicarbonate

Drug: Sodium bicarbonate

Saline

ACTIVE COMPARATOR

saline infusion

Drug: saline

Interventions

Sodium bicarbonateDRUG

3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure

Sodium bicarbonate
salineDRUG

0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure

Saline

Eligibility Criteria

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

You may qualify if:

  • age\>18 years, no upper limits
  • diabetes treated with insulin or oral hypoglycemic agents
  • serum creatinine \>=1.1 and
  • resting estimated glomerular filtration rate \<60ml/min/1.73 square meter

You may not qualify if:

  • serum creatinine \>=8mg/dL
  • resting estimated GFR \<15ml/min/1.73 square meter
  • end stage renal disease on hemodialysis
  • multiple myeloma
  • uncontrolled hypertension (systolic BP \>160mmHg or diastolic BP\>100mmHg)
  • acute myocardial infarction
  • emergent coronary angioplasty or angiography
  • recent use of contrast within 2 days
  • allergic reaction to contrast
  • pregnancy
  • allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

RECRUITING

Busan Saint Mary Hospital

Busan, South Korea

RECRUITING

Soonchunhyang University Hospital, Cheonan

Cheonan, South Korea

RECRUITING

Kangwon National University Hospital

Chuncheon, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Gangneung Asan Hospital

Gangneung, South Korea

RECRUITING

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Soonchunhyang University Seoul Hospital

Seoul, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sodium BicarbonateSodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Seong-Wook Park, MD, PhD

    Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong-Wook Park, MD, PhD

CONTACT

2-3010-3153swpark@amc.seoul.kr

Seung-Whan Lee, MD, PhD

CONTACT

2-3010-3170seungwlee@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 31, 2009

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

January 1, 2010

Last Updated

July 31, 2009

Record last verified: 2009-07

Locations

KR(9)