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Status unknownNCT00950079Updated Jul 31, 2009

Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography

A Phase 4 interventional study of Sodium bicarbonate and saline in Contrast Induced Nephropathy, sponsored by CardioVascular Research Foundation, Korea. Status unknown at 9 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-31.

Sponsored by CardioVascular Research Foundation, Korea · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
368
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Contrast induced nephropathy (CIN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity or mortality, and cost. CIN has been reported to account for 10% of hospital acquired renal failure. Several strategies or medications were tried to prevent CIN. Of these, mucomyst and normal saline infusion are effective to prevent CIN. Sodium bicarbonate has shown mixed results from recent randomized trials. Moreover,limited data have been available for preventing CIN in diabetic renal dysfunction undergoing coronary angiography or intervention. Our hypothesis is that addition of sodium bicarbonate will be more efficacious than normal saline in preventing CIN at above situation.

02

Conditions studied

  • Contrast Induced Nephropathy

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Keywords

  • sodium bicarbonate
  • diabetes mellitus
  • coronary angiography or intervention
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 368 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

CardioVascular Research Foundation, Korea is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
368 participants (estimated)

Study arms

  • Experimental
    Sodium bicarbonate

    sodium bicarbonate

    Drug: Sodium bicarbonate

  • Active comparator
    Saline

    saline infusion

    Drug: saline

Interventions

  • DrugSodium bicarbonate

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

  • Drugsaline

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

06

What researchers measure

Primary outcomes

  1. Incidence of contrast-induced nephropathy

    Time frame: 24 and 48 hours after angiography or intervention

Secondary outcomes

  1. all-cause mortality

    Time frame: 30 days after index angiography

  2. stroke

    Time frame: 30 days after index angiography

  3. Dialysis

    Time frame: 30 days after index angiography

  4. Myocardial infarction

    Time frame: 30 days after index angiography

  5. all-cause mortality

    Time frame: 30 days to 6 months after index angiography

  6. stroke

    Time frame: 30 days to 6 months after index angiography

  7. dialysis

    Time frame: 30 days to 6 months after index angiography

  8. myocardial infarction

    Time frame: 30 days to 6 months after index angiography

07

Study locations

9 of 9 sites recruiting
  • Soonchunhyang University Bucheon Hospital
    Bucheon, Korea, Republic of
    • Nae-Hee Lee, MD, PhD · Contact
    • Nae-Hee Lee, MD, PhD · Principal investigator
    Recruiting
  • Busan Saint Mary Hospital
    Busan, Korea, Republic of
    • Jae-Sik Jang, MD · Contact
    • Jae-Sik Jang, MD · Principal investigator
    Recruiting
  • Soonchunhyang University Hospital, Cheonan
    Cheonan, Korea, Republic of
    • Won-Yong Shin, MD, PhD · Contact
    • Dong-Gyu Jin, MD, PhD · Principal investigator
    Recruiting
  • Kangwon National University Hospital
    Chuncheon, Korea, Republic of
    • Bong-Ki Lee, MD, PhD · Contact
    • Bong-Ki Lee · Contact
    • Bong-Ki Lee, MD, PhD · Principal investigator
    Recruiting
  • Chungnam National University Hospital
    Daejeon, Korea, Republic of
    • In-Whan Seong, MD, PhD · Contact
    • In-Whan Seong, MD, PhD · Principal investigator
    Recruiting
  • Gangneung Asan Hospital
    Gangneung, Korea, Republic of
    • Sang-Sik Cheong · Contact
    • Sang-Sik Cheong, MD, PhD · Principal investigator
    Recruiting
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
    Recruiting
  • Soonchunhyang University Seoul Hospital
    Seoul, Korea, Republic of
    • Min-Su Hyun, MD, PhD · Contact
    • Min-Su Hyun, MD, PhD · Principal investigator
    Recruiting
  • Ulsan University Hospital
    Ulsan, Korea, Republic of
    • Sang-Gon Lee, MD, PhD · Contact
    • Sang-Gon Lee, MD, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00950079
Lead sponsor
CardioVascular Research Foundation, Korea
First posted
Jul 31, 2009
Start date
Feb 2008
Primary completion
Aug 2009 (estimated)
Completion
Jan 2010 (estimated)
Last update
Jul 31, 2009

Study contacts

Seong-Wook Park, MD, PhD
Contact
swpark@amc.seoul.kr
2-3010-3153 ext. 82
Seung-Whan Lee, MD, PhD
Contact
seungwlee@amc.seoul.kr
2-3010-3170 ext. 82
Seong-Wook Park, MD, PhD
principal investigator · Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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